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

RADIANCE FOUNDATION BROAD SPECTRUM SPF 20 — NUDE 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)

RADIANCE FOUNDATION BROAD SPECTRUM SPF 20 — NUDE JAFRA octinoxate, zinc oxide cream

Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-255 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:68828-255-02 1 TUBE in 1 BOX contains a TUBE (68828-255-01) 1 NDC:68828-255-01 30 mL in 1 TUBE This package is contained within the BOX (68828-255-02)

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 (68828-255)

Revised: 06/2019 JAFRA COSMETICS INTERNATIONAL