Face Protector Spf 40 (Octinoxate Oxybenzone Octisalate Octocrylene Titanium Dioxide) Lotion [Jafra Cosmetics International] -

FACE PROTECTOR SPF 40 (OCTINOXATE OXYBENZONE OCTISALATE OCTOCRYLENE TITANIUM DIOXIDE) LOTION [JAFRA COSMETICS INTERNATIONAL]
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NDC	68828-054-13
Set ID	56b5e11c-bf43-414e-ae17-4cebc47ae27b
Category	HUMAN OTC DRUG LABEL
Packager	JAFRA COSMETICS INTERNATIONAL
Generic Name
Product Class
Product Number
Application Number	PART352

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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

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

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