![RADIANCE FOUNDATION BROAD SPECTRUM SPF 20 - TAWNY JAFRA (OCTINOXATE, ZINC OXIDE) CREAM [JAFRA COSMETICS INTERNATIONAL]](https://medic.hrt.org//dailymed/images/2f26bf56-7cb6-4c19-ad24-8ee0b35aebd5/COLR-188UCRoyalJellyMkupSpf20TesterUS.jpg)
| NDC | 68828-258-01, 68828-258-02 |
| Set ID | 2f26bf56-7cb6-4c19-ad24-8ee0b35aebd5 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | JAFRA COSMETICS INTERNATIONAL |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
-
DOSAGE & ADMINISTRATION
- 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
-
INACTIVE INGREDIENT
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
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
RADIANCE FOUNDATION BROAD SPECTRUM SPF 20 - TAWNY JAFRA
octinoxate, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-258 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 6.8 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) CYCLOMETHICONE (UNII: NMQ347994Z) HYDROXYPROPYLCOCOATE PEG-8 DIMETHICONE (UNII: 8TE0BZU36S) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SQUALANE (UNII: GW89575KF9) DI-PPG-3 MYRISTYL ETHER ADIPATE (UNII: T32481VTXW) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) DIMETHICONE (UNII: 92RU3N3Y1O) PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) BORON NITRIDE (UNII: 2U4T60A6YD) ROYAL JELLY (UNII: L497I37F0C) PROPANEDIOL (UNII: 5965N8W85T) SODIUM CHLORIDE (UNII: 451W47IQ8X) DMDM HYDANTOIN (UNII: BYR0546TOW) RICE BRAN (UNII: R60QEP13IC) ROSEMARY (UNII: IJ67X351P9) HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP) TOCOPHEROL (UNII: R0ZB2556P8) PANTHENOL (UNII: WV9CM0O67Z) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PEG-4 LAURATE (UNII: AYF4VM3N1Z) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) BIOSACCHARIDE GUM-4 (UNII: 9XRL057X90) CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78) FERRIC OXIDE RED (UNII: 1K09F3G675) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) FERROSOFERRIC OXIDE (UNII: XM0M87F357) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-258-02 8 in 1 CARTON 08/11/2015 1 NDC:68828-258-01 8 mL in 1 TUBE; Type 0: Not a Combination Product 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 Business Operations Jafra Manufacturing, S.A. de C.V 814732061 manufacture(68828-258)
