JAFRA BRIGHTENING BRIGHTENING SPF 15- otinoxate, zinc oxide lotion

Jafra Brightening by

Drug Labeling and Warnings

Jafra Brightening by is a Otc medication manufactured, distributed, or labeled by Jafra Cosmetics International Inc , Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sunscreen Active ingredients (SPF 15): Octinoxate, Zinc Oxide

Purpose: Sunscreen

Keep out of reach of children

Discontinue use if signs of irritation appear

Cautions: for external use only. Avoid contact with eyes.

To use: In the morning, smooth over cleansed face and throat.

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].

PRINCIPAL DISPLAY PANEL

Jafra

Brightening

Brightening Lotion SPF 15

Locion Facial Humectante Con Efecto Aclarador
con *FPS 15

50 ml 1.7 Fl Oz

INGREDIENTS AND APPEARANCE

JAFRA BRIGHTENING  BRIGHTENING SPF 15
otinoxate, zinc oxide lotion

Product 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)