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

FACE PROTECTOR by

Drug Labeling and Warnings

FACE PROTECTOR by is a Otc medication manufactured, distributed, or labeled by JAFRA COSMETICS INTERNATIONAL, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

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

PURPOSE

PURPOSE: SUNSCREEN

INACTIVE INGREDIENT

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.

INDICATIONS & USAGE

FACE PROTECTOR SPF 40

DOSAGE & ADMINISTRATION

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

STOP USE

DISCONTINUE USE IF IRRITATION OCCURS.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

PRINCIPAL DISPLAY PANEL

JAFRA SUN

FACE PROTECTOR SPF 40

WARNINGS

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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
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

Inactive Ingredients
Ingredient Name	Strength
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)

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

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

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