LAB SERIES SKINCARE FOR MEN BB TINTED MOISTURIZER BROAD SPECTRUM SPF 35: Package Insert and Label Information

LAB SERIES SKINCARE FOR MEN BB TINTED MOISTURIZER BROAD SPECTRUM SPF 35- octinoxate, octisalate, oxybenzone, titanium dioxide and zinc oxide liquid
Aramis 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.

Drug Facts

Active Ingredients	Purpose
Octinoxate 7.40%	Sunscreen
Octisalate 4.00%	Sunscreen
Oxybenzone 2.50%	Sunscreen
Titanium Dioxide 2.20%	Sunscreen
Zinc Oxide 2.00%	Sunscreen

Uses

• Helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

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 a 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

• Apply liberally 15 minutes before sun exposure
• Reapply at least every two 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 value 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 of age: ask a doctor

Inactive Ingredients

WATER • TRIOCTYLDODECYL CITRATE • METHYL TRIMETHICONE • DIMETHICONE • OCTYLDODECYL STEAROYL STEARATE • BUTYLENE GLYCOL • PHENYL TRIMETHICONE • PENTYLENE GLYCOL • GLYCERYL STEARATE • BEHENYL ALCOHOL • POLYMETHYLSILSESQUIOXANE • PEG-40 STEARATE • POLYGLYCERYL-10 PENTASTEARATE • ACETYL GLUCOSAMINE • TOCOPHERYL ACETATE • SODIUM HYALURONATE • LECITHIN • SQUALANE • SIGESBECKIA ORIENTALIS (ST. PAUL’S WORT) EXTRACT • HORDEUM VULGARE (BARLEY) EXTRACT • TRITICUM VULGARE (WHEAT) GERM EXTRACT • LAMINARIA SACCHARINA EXTRACT • CUCUMIS SATIVUS (CUCUMBER) FRUIT EXTRACT • PYRUS MALUS (APPLE) FRUIT EXTRACT • SCUTELLARIA BAICALENSIS ROOT EXTRACT • CAFFEINE • CHOLESTEROL • GLYCERIN • SODIUM PCA • POLYGLYCERYL-6 POLYRICINOLEATE • ORYZANOL • TREHALOSE • OCTYLDODECYL NEOPENTANOATE • ACETYL HEXAPEPTIDE-8 • PROPYLENE GLYCOL STEARATE • PROPYLENE GLYCOL LAURATE • ISOPROPYL MYRISTATE • ALUMINA • SODIUM STEAROYL LACTYLATE • XANTHAN GUM • SUCROSE • UREA • POLYMETHYL METHACRYLATE • DISODIUM EDTA • AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER • SILICA • ISOPROPYL TITANIUM TRIISOSTEARATE • SORBITAN LAURATE • POLYSORBATE 20 • POLYQUATERNIUM-51 • STEARIC ACID • LINOLEIC ACID • GLYCYRRHETINIC ACID • PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE • PHENOXYETHANOL • CHLORPHENESIN • SODIUM DEHYDROACETATE • [+/- IRON OXIDES (CI 77491, CI 77492, CI 77499) • TITANIUM DIOXIDE (CI 77891)] <ILN37913>

Other information

• Protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL — 50 ml Carton

LAB
SERIES
SKINCARE FOR MEN

BB TINTED
MOISTURIZER
BROAD
SPECTRUM
SPF 35

oil free

TREAT

1.7 FL. OZ./OZ. LIQ. 50 ml e

LAB SERIES SKINCARE FOR MEN BB TINTED MOISTURIZER BROAD SPECTRUM SPF 35 octinoxate, octisalate, oxybenzone, titanium dioxide, and zinc oxide liquid

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42472-002 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (OCTINOXATE) OCTINOXATE 74 mg in 1 mL OCTISALATE (OCTISALATE) OCTISALATE 40 mg in 1 mL OXYBENZONE (OXYBENZONE) OXYBENZONE 25 mg in 1 mL TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 22 mg in 1 mL ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 20 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER TRIOCTYLDODECYL CITRATE METHYL TRIMETHICONE DIMETHICONE OCTYLDODECYL STEAROYL STEARATE BUTYLENE GLYCOL PHENYL TRIMETHICONE PENTYLENE GLYCOL GLYCERYL MONOSTEARATE DOCOSANOL PEG-40 STEARATE N-ACETYLGLUCOSAMINE .ALPHA.-TOCOPHEROL ACETATE HYALURONATE SODIUM SQUALANE WHEAT GERM SACCHARINA LATISSIMA CUCUMBER APPLE SCUTELLARIA BAICALENSIS ROOT CAFFEINE CHOLESTEROL GLYCERIN SODIUM PYRROLIDONE CARBOXYLATE ORYZANOL TREHALOSE OCTYLDODECYL NEOPENTANOATE ACETYL HEXAPEPTIDE-8 PROPYLENE GLYCOL MONOSTEARATE PROPYLENE GLYCOL MONOLAURATE ISOPROPYL MYRISTATE ALUMINUM OXIDE SODIUM STEAROYL LACTYLATE XANTHAN GUM SUCROSE UREA EDETATE DISODIUM AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER SILICON DIOXIDE ISOPROPYL TITANIUM TRIISOSTEARATE SORBITAN MONOLAURATE POLYSORBATE 20 STEARIC ACID LINOLEIC ACID ENOXOLONE PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) PHENOXYETHANOL CHLORPHENESIN SODIUM DEHYDROACETATE FERRIC OXIDE RED FERRIC OXIDE YELLOW FERROSOFERRIC OXIDE

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:42472-002-01 1 BOTTLE in 1 CARTON contains a BOTTLE 1 50 mL in 1 BOTTLE This package is contained within the CARTON (42472-002-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part352 04/24/2011

Labeler — Aramis Inc. (042918826)

Establishment
Name	Address	ID/FEI	Operations
ESTEE LAUDER COSMETICS, LTD		255175580	MANUFACTURE (42472-002)

Establishment
Name	Address	ID/FEI	Operations
ESTEE LAUDER N.V		370151326	MANUFACTURE (42472-002)

Establishment
Name	Address	ID/FEI	Operations
LEN-RON MANUFACTURING DIVISION OF ARAMIS INC		809771152	MANUFACTURE (42472-002)

Establishment
Name	Address	ID/FEI	Operations
PADC 1		949264774	REPACK (42472-002), RELABEL (42472-002)

Establishment
Name	Address	ID/FEI	Operations
WHITMAN LABORATORIES, LTD.		216866277	MANUFACTURE (42472-002)

Establishment
Name	Address	ID/FEI	Operations
ESTEE LAUDER COMPANY, THE		828534516	REPACK (42472-002), RELABEL (42472-002)

Establishment
Name	Address	ID/FEI	Operations
ESTEE LAUDER COSMETICS, LTD		244669714	MANUFACTURE (42472-002)

Establishment
Name	Address	ID/FEI	Operations
NORTHTEC INC		943871157	REPACK (42472-002), RELABEL (42472-002)

Establishment
Name	Address	ID/FEI	Operations
ESTEE LAUDER COSMETICS, LTD.		202952982	MANUFACTURE (42472-002)

Revised: 11/2020 Aramis Inc.