Radiance Foundation Broad Spectrum SPF 20 – Fair JAFRA: Package Insert and Label Information

RADIANCE FOUNDATION BROAD SPECTRUM SPF 20 — FAIR JAFRA- octinoxate and zinc oxide cream
JAFRA COSMETICS INTERNATIONAL

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.

Octinoxate 3% ……………… Sunscreen

Zinc Oxide 6.8% ……………. Sunscreen

Uses

  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away

Stop use and ask a doctor if rash occurs

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

Water/Aqua, Titanium Dioxide, Triethoxycaprylysilane, Caprylic Capric Triglyceride, Polyhydroxystearic Acid, Cyclomethicone, Hydroxypropylcocoate PEG-8 Diemthicone, C12-15 Alkyl Benzoate, Phenyl Dimethicone, Phenyl Trimethicone, Cyclopentasiloxane, Dimethicone/Vinyl Dimethicone Crosspolymer, Squalane, Di-PPG-3 Myristyl Ether Adipate Caprylyl Methicone, Dimethicone, PEG-10 Dimethicone, Disteardimonium Hectorite, Boron Nitride, Royal Jelly, Propanediol, Sodium Chloride, DMDM Hydantoin, Dextin Palmitate, Oryza Sativa (Rice) Bran Extract, Rosamarinus Officinalis (Rosemary) Leaf Extract, Helianthus Anuus (Sunflower) Extract, Tocopherol, Panthenol, Tocopheryl Acetate, PEG-4 Laurate, Iodopropynyl Butylcarbamate, Withania Somniferia (Winter Cherry) Extract, Nelumbo Nucifera (Lotus) Extract, Biosacchardie Gum-4, Chondrus Crispus (Carrageenan) Extract, Smithsonite Extract, Iron Oxides/CI 77491/CI 77492/CI 77499

JAFRA

Royal Jelly

Raidiance Foundation

Broad Spectrum SPF 20

30 ml 1 FL OZ (US)

box
(click image for full-size original)
RADIANCE FOUNDATION BROAD SPECTRUM SPF 20 — FAIR JAFRA
octinoxate, zinc oxide cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-252
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 3 g in 100 mL
ZINC OXIDE (ZINC CATION) ZINC CATION 6.8 g in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER
TITANIUM DIOXIDE
TRIETHOXYCAPRYLYLSILANE
POLYHYDROXYSTEARIC ACID (2300 MW)
CYCLOMETHICONE
HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE
ALKYL (C12-15) BENZOATE
PHENYL TRIMETHICONE
CYCLOMETHICONE 5
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)
SQUALANE
DI-PPG-3 MYRISTYL ETHER ADIPATE
CAPRYLYL TRISILOXANE
DIMETHICONE
PEG-10 DIMETHICONE (600 CST)
DISTEARDIMONIUM HECTORITE
BORON NITRIDE
ROYAL JELLY
PROPANEDIOL
SODIUM CHLORIDE
DMDM HYDANTOIN
RICE BRAN
ROSEMARY
HELIANTHUS ANNUUS FLOWERING TOP
TOCOPHEROL
PANTHENOL
.ALPHA.-TOCOPHEROL ACETATE
PEG-4 LAURATE
IODOPROPYNYL BUTYLCARBAMATE
BIOSACCHARIDE GUM-4
CHONDRUS CRISPUS CARRAGEENAN
FERRIC OXIDE RED
FERRIC OXIDE YELLOW
FERROSOFERRIC OXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68828-252-02 1 TUBE in 1 BOX contains a TUBE (68828-252-01)
1 NDC:68828-252-01 30 mL in 1 TUBE This package is contained within the BOX (68828-252-02)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 08/11/2015
Labeler — JAFRA COSMETICS INTERNATIONAL (041676479)
Registrant — JAFRA COSMETICS INTERNATIONAL (041676479)
Establishment
Name Address ID/FEI Operations
Jafra Manufacturing, S.A. de C.V 814732061 manufacture (68828-252)

Revised: 02/2019 JAFRA COSMETICS INTERNATIONAL

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