SUN FACE PROTECTOR SUNSCREEN BROAD SPECTRUM SPF 50 JAFRA- avobenzone, homosalate, octisalate,octocrylene, oxybenzone lotion

Sun Face Protector Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Sun Face Protector Sunscreen Broad Spectrum SPF 50 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

Active ingredients       Purpose

Avobenzone 3%        Sunscreen

Homosalate 10%       Sunscreen

Octisalate 5%            Sunscreen

Octocrylene 10%        Sunscreen

Oxybenzone 5%        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

Keep out of reach of children

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

If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

apply liberally 15 minutes before sun exposure

use a water resistant sunscreen if swimming or sweating

reapply at least every 2 hours

children under 6 months: ask a doctor

Sun Protection Measures

Inactive ingredients

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Acrylates/Octylacrylamide Copolymer, Adipic Acid/Diglycol Crosspolymer, Allantoin, Alluminium Starch Octenylsuccinate, Arachidyl Alcohol,  Arachidyl Glucoside, Arginine, Avena Sativa (Oat) Kernel Extract, Azadirachta Indica Extract, Behenyl Alcohol, Bisabolol, Butylene Glycol, Chlorphenesin, Cyclopentasiloxane, Dimethicone Copolyol, Disodium EDTA, Ethoxylated Castor Oil, Ethylhexyglycerin, Fragrance/Parfum, Glyceryl Stearate, Glycyrrhiza Glabra (Licorice) Extract, Ipomoea Batatas Tuber Extract, Iron Oxides/CI 77491/CI 77492/CI 77499, Lauroyl Lysine, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Methylisothiazolinone, Mica, Moringa Oliefera Extract, Panthenol, PEG-100 Stearate, PEG-12 Dimethicone, Polysorbate 20, Silica, Styrene/Acrylates Copolymer, Tagetus Erecta (African Marigold) Extract, Tocopheryl Acetate, Vetivera Zinzanoids (Khus Root) Extract, Water/Aqua, Withania Somnifera (Winter Cherry) Extract

PRINCIPAL DISPLAY PANEL

Jafra Sun Face Protector Sunscreen broad spectrum SPF 50+

50 ml 1.7 FL OZ (US)

INGREDIENTS AND APPEARANCE

SUN FACE PROTECTOR SUNSCREEN BROAD SPECTRUM SPF 50  JAFRA
avobenzone, homosalate, octisalate,octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-188
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
ALLANTOIN (UNII: 344S277G0Z)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
ARGININE (UNII: 94ZLA3W45F)
OAT (UNII: Z6J799EAJK)
AZADIRACHTA INDICA BARK (UNII: G580B439YI)
DOCOSANOL (UNII: 9G1OE216XY)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CHLORPHENESIN (UNII: I670DAL4SZ)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LICORICE (UNII: 61ZBX54883)
SWEET POTATO (UNII: M9WGG9Z9GK)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
LAUROYL LYSINE (UNII: 113171Q70B)
TEA TREE OIL (UNII: VIF565UC2G)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
MICA (UNII: V8A1AW0880)
MORINGA OLEIFERA BARK (UNII: 1X2218R709)
PANTHENOL (UNII: WV9CM0O67Z)
PEG-100 STEARATE (UNII: YD01N1999R)
PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
TAGETES ERECTA FLOWER (UNII: UH5X33P33E)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CHRYSOPOGON ZIZANIOIDES ROOT (UNII: 37TB8LUP9Z)
WATER (UNII: 059QF0KO0R)
WITHANIA SOMNIFERA FLOWER (UNII: 2HZ95R7082)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-188-02	1 in 1 PACKAGE	02/27/2014
1	NDC: 68828-188-01	50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68828-188-04	1 in 1 PACKAGE	02/27/2014
2	NDC: 68828-188-03	75 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 final	part352	02/27/2014

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(68828-188)