![JAFRA BRIGHTENING BRIGHTENING SPF 15 (OTINOXATE, ZINC OXIDE) LOTION [JAFRA COSMETICS INTERNATIONAL INC ]](https://medic.hrt.org//dailymed/images/deedf9a3-b6f9-48e3-949d-a4be343d7fdb/carton.jpg)
| NDC | 68828-101-01 |
| Set ID | deedf9a3-b6f9-48e3-949d-a4be343d7fdb |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Jafra Cosmetics International Inc |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
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ACTIVE INGREDIENT
Sunscreen Active ingredients (SPF 15): Octinoxate, Zinc Oxide
Other ingredients: Water/aqua, Dimethicone, Tridecyl Neopentanoate, Glyceryl Stearate, PEG-100 Stearate,Glycerin, Polyacrylamide, C13-14 Isoparrafin, Laureth-7, Palmaria Palmata (Red seaweed) Extract, Acrylates Copolymer, Cyclomethicone, DMDM Hydantoin, Iodopropynyl Butylcarbamate, Cetyl Alcohol, Glycyrrhiza Glabra (Licorice) Extract, Phyllanthus Emblica Extrtact, Withania Somnifera (Winter Cherry) Extract, Biosaccharide Gum-4, Chondrus Crispus (carrageenan) Extract, Fragrance/parfum, Panthenol, Tocopheryl Acetate, Xanthan Gum, Trisodium EDTA [Fragrance/parfum contains Benzyl Benzoate].
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INGREDIENTS AND APPEARANCE
JAFRA BRIGHTENING BRIGHTENING SPF 15
otinoxate, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 2.5 g in 50 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 2 g in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) TRIDECYL NEOPENTANOATE (UNII: 3Z8H1DA7J5) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERIN (UNII: PDC6A3C0OX) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) LAURETH-7 (UNII: Z95S6G8201) DULSE (UNII: 7832HOY4ZQ) CYCLOMETHICONE (UNII: NMQ347994Z) DMDM HYDANTOIN (UNII: BYR0546TOW) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) CETYL ALCOHOL (UNII: 936JST6JCN) LICORICE (UNII: 61ZBX54883) PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576) WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082) CHONDRUS CRISPUS (UNII: OQS23HUA1X) PANTHENOL (UNII: WV9CM0O67Z) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) XANTHAN GUM (UNII: TTV12P4NEE) EDETATE TRISODIUM (UNII: 420IP921MB) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-101-01 1 in 1 CARTON 05/15/2012 1 50 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 05/15/2012 Labeler - Jafra Cosmetics International Inc (041676479) Registrant - Jafra Cosmetics International Inc (041676479) Establishment Name Address ID/FEI Business Operations Jafra Manufacturing, S.A. de C.V. 814732061 manufacture(68828-101)
