FACE PROTECTOR SPF 40

FACE PROTECTOR SPF 40- octinoxate oxybenzone octisalate octocrylene titanium dioxide lotion
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.

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SUNSCREEN ACTIVE INGREDIENT (SPF 40):
OCTINOXATE/ETHYLHEXYL METHOXYCINNAMATE, OXYBENZONE/BENZOPHENONE-3, OCTISALATE/ETHYLHEXYL SALICYLATE, OCTOCRYLENE, TITANIUM DIOXIDE/CI 77891.

PURPOSE: SUNSCREEN

OTHER INGREDIENTS: WATER/AQUA, C12-15 ALKYL BENZOATE, ALUMINA, DIMETHICONE, ETHYLHEXYL ETHYLHEXANOATE, SODIUM DIHYDROXYCETYL PHOSPHATE, BUTYLENE GLYCOL, GLYCERYL STEARATE SE, ADIPIC ACID/DIETHYLENE GLYCOL/GLYCERIN CROSSPOLYMER, PANTHENOL, TOCOPHERYL ACETATE, AVENA SATIVA (OAT) KERNEL EXTRACT, PVP/EICOSENE COPOLYMER, CETYL ALCOHOL, XANTHAN GUM, BEESWAX/CERA ALBA, FRAGRANCE/PARFUM, IRON OXIDES/CI 77491/CI 77492/CI 77499, PEG-4 LAURATE, IODOPROPYNYL BUTYLCARBAMATE, DMDM HYDANTOIN, TRISODIUM EDTA.

FACE PROTECTOR SPF 40

TO USE: APPLY SUNSCREEN PRODUCT 20 MINUTES BEFORE EXPOSURE. RE-APPLY FREQUENTLY TO MAINTAIN PROTECTION, ESPECIALLY AFTER PERSPIRING, SWIMMING OR TOWELING.

DISCONTINUE USE IF IRRITATION OCCURS.

KEEP OUT OF REACH OF CHILDREN.

JAFRA SUN

FACE PROTECTOR SPF 40

CAUTION: FOR EXTERNAL USE ONLY. AVOID CONTACT WITH EYES.

FACE PROTECTOR SPF 40
octinoxate oxybenzone octisalate octocrylene titanium dioxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68828-054
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ALUMINUM OXIDE (UNII: LMI26O6933)
DIMETHICONE (UNII: 92RU3N3Y1O)
ETHYLHEXYL ETHYLHEXANOATE (UNII: 430RJA6715)
SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
DIETHYLENE GLYCOL ADIPATE (UNII: 6KE5V549E0)
OAT (UNII: Z6J799EAJK)
POVIDONE K30 (UNII: U725QWY32X)
CETYL ALCOHOL (UNII: 936JST6JCN)
YELLOW WAX (UNII: 2ZA36H0S2V)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
DMDM HYDANTOIN (UNII: BYR0546TOW)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
PANTHENOL (UNII: WV9CM0O67Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE TRISODIUM (UNII: 420IP921MB)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:68828-054-13	50 mL in 1 TUBE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	04/24/2012

Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)

Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)

Name	Address	ID/FEI	Business Operations
Establishment
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture