DECORTE SHEER BRILLIANCE 10: Package Insert and Label Information

DECORTE SHEER BRILLIANCE 10- octinoxate and zinc oxide lotion
DECORTE SHEER BRILLIANCE 20- octinoxate and zinc oxide lotion
DECORTE SHEER BRILLIANCE 30- octinoxate and zinc oxide lotion
DECORTE SHEER BRILLIANCE 40- octinoxate and zinc oxide lotion
KOSE AMERICA, INC.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

DECORTÉ Sheer Brilliance

Drug Facts

Active ingredients

OCTINOXATE

6.99%

ZINC OXIDE

6.86%

Purpose

Sunscreen

Sunscreen

Use

  • helps prevent sunburn

Warnings

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask doctor if rash occurs.

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10 a.m. — 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
    • children under 6 months: Ask a doctor

Inactive ingredients:

WATER (AQUA) •CYCLOMETHICONE •ALCOHOL •LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE •ISOTRIDECYL ISONONAOATE •TRIMETHYLSILOXYSILICATE •PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE •TRIETHYLHEXANOIN •ACORUS CALAMUS ROOT EXTRACT •ALGAE OLIGOSACCHARIDES •ASTAXANTHIN •EUGENIA CARYOPHYLLUS (CLOVE) FLOWER EXTRACT •HAEMATOCOCCUS PLUVIALIS EXTRACT •PALMITOYL PENTAPEPTIDE-4 •RHODIOLA SACRA ROOT EXTRACT •SOLUBLE COLLAGEN •TOCOPHEROL •ZIZYPHUS JUJUBA FRUIT EXTRACT •ALGIN •ALUMINUM HYDROXIDE •BHT •BUTYLENE GLYCOL •CAPRYLIC/CAPRICTRIGLYCERIDE •CARBOMER •CELLULOSE •DIMETHECONE/VINYL DIMETHICONE CROSSPOLYMER •DISTEAR DIMONIUM HECTORITE •GLYCERIN •HYDROGEN DIMETHICONE •HYDROGENATED LECITHIN •ISOPROPYL TITANIUM TRIISOSTEARATE •PHYTOSTERYL OLEATE •POLYSORBATE 20 •SODIUM CHLORIDE •SODIUM LACTATE •SQUALANE •TRIETHOXYCAPRYLYLSILANE •PHENOXYETHANOL •FRAGRANCE (PARFUM) •MAY CONTAIN (+/-): IRON OXIDES (CI 77491) •IRON OXIDES (CI 77492) •IRON OXIDES (CI 77499) •MICA •TITANIUM DIOXIDE (CI 77891)

Other information

  • Protect this product from excessive heat and direct sun

Principal Display Panel — Decorte Sheet Brilliance 10 Level 50 ml Carton Label

DECORTÉ

SHEER BRILLIANCE

Soft Lifting Tint

Broad Spectrum SPF 32

Sunscreen

NET WT. 1.7 FL. OZ. / 50 ml e

Principal Display Panel -- Decorte Sheet Brilliance 10 Level 50 ml Carton Label
(click image for full-size original)

Principal Display Panel — Decorte Sheet Brilliance 20 Level 50 ml Carton Label

DECORTÉ

SHEER BRILLIANCE

Soft Lifting Tint

Broad Spectrum SPF 32

Sunscreen

NET WT. 1.7 FL. OZ. / 50 ml e

Principal Display Panel -- Decorte Sheet Brilliance 20 Level 50 ml Carton Label
(click image for full-size original)

Principal Display Panel — Decorte Sheet Brilliance 30 Level 50 ml Carton Label

DECORTÉ

SHEER BRILLIANCE

Soft Lifting Tint

Broad Spectrum SPF 32

Sunscreen

NET WT. 1.7 FL. OZ. / 50 ml e

Principal Display Panel -- Decorte Sheet Brilliance 30 Level 50 ml Carton Label
(click image for full-size original)

Principal Display Panel — Decorte Sheet Brilliance 40 Level 50 ml Carton Label

DECORTÉ

SHEER BRILLIANCE

Soft Lifting Tint

Broad Spectrum SPF 32

Sunscreen

NET WT. 1.7 FL. OZ. / 50 ml e

Principal Display Panel -- Decorte Sheet Brilliance 40 Level 50 ml Carton Label
(click image for full-size original)
DECORTE SHEER BRILLIANCE 10
octinoxate, zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66820-0110
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 3.9 g in 50 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 3.8 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CYCLOMETHICONE
ALCOHOL
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
ISOTRIDECYL ISONONANOATE
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
TRIETHYLHEXANOIN
ACORUS CALAMUS ROOT
HYDROLYZED GELIDIUM ELEGANS POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED GELIDIUM LINGULATUM POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED GELIDIUM REX POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED GELIDIUM SESQUIPEDALE POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED GRACILARIA CHILENSIS POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED GRACILARIA VERMICULOPHYLLA POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED PTEROCLADIELLA TENUIS POLYSACCHARIDES (ENZYMATIC; 750 MW)
ASTAXANTHIN
CLOVE
HAEMATOCOCCUS PLUVIALIS
PALMITOYL PENTAPEPTIDE-4
RHODIOLA SACRA ROOT
MARINE COLLAGEN, SOLUBLE
TOCOPHEROL
JUJUBE FRUIT
SODIUM ALGINATE
ALUMINUM HYDROXIDE
BUTYLATED HYDROXYTOLUENE
BUTYLENE GLYCOL
MEDIUM-CHAIN TRIGLYCERIDES
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
POWDERED CELLULOSE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
DISTEARDIMONIUM HECTORITE
GLYCERIN
HYDROGEN DIMETHICONE (20 CST)
HYDROGENATED SOYBEAN LECITHIN
ISOPROPYL TITANIUM TRIISOSTEARATE
HYDROLYZED ORYZANOL OLEATES
POLYSORBATE 20
SODIUM CHLORIDE
SODIUM LACTATE
SQUALANE
TRIETHOXYCAPRYLYLSILANE
PHENOXYETHANOL
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MICA
TITANIUM DIOXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66820-0110-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 50 mL in 1 BOTTLE This package is contained within the CARTON (66820-0110-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 05/01/2018
DECORTE SHEER BRILLIANCE 20
octinoxate, zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66820-0120
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 3.9 g in 50 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 3.8 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CYCLOMETHICONE
ALCOHOL
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
ISOTRIDECYL ISONONANOATE
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
TRIETHYLHEXANOIN
ACORUS CALAMUS ROOT
HYDROLYZED GELIDIUM ELEGANS POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED GELIDIUM LINGULATUM POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED GELIDIUM REX POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED GELIDIUM SESQUIPEDALE POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED GRACILARIA CHILENSIS POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED GRACILARIA VERMICULOPHYLLA POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED PTEROCLADIELLA TENUIS POLYSACCHARIDES (ENZYMATIC; 750 MW)
ASTAXANTHIN
CLOVE
HAEMATOCOCCUS PLUVIALIS
PALMITOYL PENTAPEPTIDE-4
RHODIOLA SACRA ROOT
MARINE COLLAGEN, SOLUBLE
TOCOPHEROL
JUJUBE FRUIT
SODIUM ALGINATE
ALUMINUM HYDROXIDE
BUTYLATED HYDROXYTOLUENE
BUTYLENE GLYCOL
MEDIUM-CHAIN TRIGLYCERIDES
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
POWDERED CELLULOSE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
DISTEARDIMONIUM HECTORITE
GLYCERIN
HYDROGEN DIMETHICONE (20 CST)
HYDROGENATED SOYBEAN LECITHIN
ISOPROPYL TITANIUM TRIISOSTEARATE
HYDROLYZED ORYZANOL OLEATES
POLYSORBATE 20
SODIUM CHLORIDE
SODIUM LACTATE
SQUALANE
TRIETHOXYCAPRYLYLSILANE
PHENOXYETHANOL
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MICA
TITANIUM DIOXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66820-0120-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 50 mL in 1 BOTTLE This package is contained within the CARTON (66820-0120-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 05/01/2018
DECORTE SHEER BRILLIANCE 30
octinoxate, zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66820-0130
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 3.9 g in 50 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 3.8 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CYCLOMETHICONE
ALCOHOL
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
ISOTRIDECYL ISONONANOATE
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
TRIETHYLHEXANOIN
ACORUS CALAMUS ROOT
HYDROLYZED GELIDIUM ELEGANS POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED GELIDIUM LINGULATUM POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED GELIDIUM REX POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED GELIDIUM SESQUIPEDALE POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED GRACILARIA CHILENSIS POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED GRACILARIA VERMICULOPHYLLA POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED PTEROCLADIELLA TENUIS POLYSACCHARIDES (ENZYMATIC; 750 MW)
ASTAXANTHIN
CLOVE
HAEMATOCOCCUS PLUVIALIS
PALMITOYL PENTAPEPTIDE-4
RHODIOLA SACRA ROOT
MARINE COLLAGEN, SOLUBLE
TOCOPHEROL
JUJUBE FRUIT
SODIUM ALGINATE
ALUMINUM HYDROXIDE
BUTYLATED HYDROXYTOLUENE
BUTYLENE GLYCOL
MEDIUM-CHAIN TRIGLYCERIDES
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
POWDERED CELLULOSE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
DISTEARDIMONIUM HECTORITE
GLYCERIN
HYDROGEN DIMETHICONE (20 CST)
HYDROGENATED SOYBEAN LECITHIN
ISOPROPYL TITANIUM TRIISOSTEARATE
HYDROLYZED ORYZANOL OLEATES
POLYSORBATE 20
SODIUM CHLORIDE
SODIUM LACTATE
SQUALANE
TRIETHOXYCAPRYLYLSILANE
PHENOXYETHANOL
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MICA
TITANIUM DIOXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66820-0130-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 50 mL in 1 BOTTLE This package is contained within the CARTON (66820-0130-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 05/01/2018
DECORTE SHEER BRILLIANCE 40
octinoxate, zinc oxide lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66820-0140
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 3.9 g in 50 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 3.8 g in 50 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CYCLOMETHICONE
ALCOHOL
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
ISOTRIDECYL ISONONANOATE
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)
PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE
TRIETHYLHEXANOIN
ACORUS CALAMUS ROOT
HYDROLYZED GELIDIUM ELEGANS POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED GELIDIUM LINGULATUM POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED GELIDIUM REX POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED GELIDIUM SESQUIPEDALE POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED GRACILARIA CHILENSIS POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED GRACILARIA VERMICULOPHYLLA POLYSACCHARIDES (ENZYMATIC; 750 MW)
HYDROLYZED PTEROCLADIELLA TENUIS POLYSACCHARIDES (ENZYMATIC; 750 MW)
ASTAXANTHIN
CLOVE
HAEMATOCOCCUS PLUVIALIS
PALMITOYL PENTAPEPTIDE-4
RHODIOLA SACRA ROOT
MARINE COLLAGEN, SOLUBLE
TOCOPHEROL
JUJUBE FRUIT
SODIUM ALGINATE
ALUMINUM HYDROXIDE
BUTYLATED HYDROXYTOLUENE
BUTYLENE GLYCOL
MEDIUM-CHAIN TRIGLYCERIDES
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE
POWDERED CELLULOSE
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
DISTEARDIMONIUM HECTORITE
GLYCERIN
HYDROGEN DIMETHICONE (20 CST)
HYDROGENATED SOYBEAN LECITHIN
ISOPROPYL TITANIUM TRIISOSTEARATE
HYDROLYZED ORYZANOL OLEATES
POLYSORBATE 20
SODIUM CHLORIDE
SODIUM LACTATE
SQUALANE
TRIETHOXYCAPRYLYLSILANE
PHENOXYETHANOL
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
MICA
TITANIUM DIOXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66820-0140-1 1 BOTTLE in 1 CARTON contains a BOTTLE
1 50 mL in 1 BOTTLE This package is contained within the CARTON (66820-0140-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 05/01/2018
Labeler — KOSE AMERICA, INC. (080407621)

Revised: 09/2021 KOSE AMERICA, INC.

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