FACE PROTECTOR BROAD SPECTRUM SPF 40 JAFRA- octinoxate, octisalate, octocrylene, oxybenzone, titanium dioxide, zinc oxide lotion

Face Protector Broad Spectrum SPF 40 by

Drug Labeling and Warnings

Face Protector Broad Spectrum SPF 40 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 ingredients        Purpose

Octinoxate  7.5 %           Sunscreen

Octisalate 5%                 Sunscreen

Octocrylene 1.5%            Sunscreen

Oxybenzone 2%               Sunscreen

Titanium Dioxide 4.25%    Sunscreen

Zin Oxide 2.9%                Sunscreen

Uses

· helps prevent sunburn
· If used as directed with other sun protection measures (see Directions),
decreases the risk of skin cancer and early skin aging caused by the sun

warning

· Keep out of reach of children. If product is swallowed, get medical help or
contact a Poison Control Center right away.

indications

· Stop use and ask a doctor if rash occurs

Warnings

· For external use only
· Do not use on damaged or broken skin
· When using this product keep out of eyes. Rinse with water to remove.

Directions

· Apply liberally 15 minutes before sun exposure

· Reapply at least every 2 hours
· Use a water resistant sunscreen if swimming or sweating
· Children under 6 months: Ask a doctor
· Sun Protection Measures. Spending time in the sun increases your risk of skin
cancer and early skin aging. To decrease this risk, regularly use a sunscreen
with broad spectrum SPF of 15 or higher and other sun protection measures
including:
· limit time in the sun, especially from 10 a.m. - 2 p.m.
· wear long-sleeve shirts, pants, hats, and sunglasses

Inactive ingredients

Adipic Acid/Diglycol Crosspolymer, Alumina, Avena Sativa (Oat) Kernel Extract, Beeswax/Cera Alba, Butylene Glycol, C12-15 Alkyl Benzoate, Cetyl Alcohol, Dimethicone, Dimethicone Copolyol, DMDM Hydantoin, Ethylhexyl Ethylhexanoate, Fragrance/Parfum, Glyceryl Stearate SE, Iodopropyl Butylcarbamate, Iron Oxides/CI 77491/CI 77492/CI 77499, Panthenol, PEG-4 Laurate, Peg-12 Dimethicone, PVP/Eicosene Copolymer, Sodium Dihydroxycetyl Phosphate Tocopheryl Acetate, Trisodium EDTA, Water/Aqua, Xanthan Gum

Principle Display

Jafra Sun

Face Protector Broad Spectrum SPF 40

UVA/UVB Protection

Cont. Net. 50 ml 1.7 FL OZ (US)

INGREDIENTS AND APPEARANCE

FACE PROTECTOR BROAD SPECTRUM SPF 40  JAFRA
octinoxate, octisalate, octocrylene, oxybenzone, titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-167
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
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	4.25 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	2.9 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ADIPIC ACID (UNII: 76A0JE0FKJ)
ALUMINUM OXIDE (UNII: LMI26O6933)
OAT (UNII: Z6J799EAJK)
WHITE WAX (UNII: 7G1J5DA97F)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
DMDM HYDANTOIN (UNII: BYR0546TOW)
ETHYLHEXYL ETHYLHEXANOATE (UNII: 430RJA6715)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
PANTHENOL (UNII: WV9CM0O67Z)
PEG-4 LAURATE (UNII: AYF4VM3N1Z)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
SODIUM DIHYDROXYCETYL PHOSPHATE (UNII: YWI33EV595)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE TRISODIUM (UNII: 420IP921MB)
WATER (UNII: 059QF0KO0R)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-167-02	1 in 1 CARTON	04/05/2013
1	NDC: 68828-167-01	50 mL in 1 TUBE; 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	04/05/2013

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(68828-167)