FACE AND BODY SUNSCREEN SPF 35 JAFRA- avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

Face and Body Sunscreen SPF 35 by

Drug Labeling and Warnings

Face and Body Sunscreen SPF 35 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

Active ingredients Purpose

Avobenzone 3% Sunscreen

Homosalate 10% Sunscreen

Octisalate 5% Sunscreen

Octocrylene 2.79% Sunscreen

Oxybenzone 6% 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. If swallowed, get medical help or contact a Posion Control Center right away.

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

rapply:

after 40 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

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 a Broad Spectrum SPF value 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

Acrylates Copolymer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Acrylates/Dimethicone Copolymer, Bisabolol, Butyrospermum Parkii(Shea Butter) Fruit, Caprylyl Glycol, Cetearyl Alcohol, Cyclopentasiloxane, DMDM Hydantoin, Fragrance/parfum, Glycerin, Glycyrrhiza Glabra (Licorice) Extract, Hexylene Glycol, Moringa Oliefera Extract, Octyldodecyl Neopentanoate, Panthenol, Phenoxyethanol. Polyester-8, Polysorbate 20, Potassium Sorbate, Sorbitan Oleate, Thermus Thermophillus Ferment, Tocopheryl Acetate, Triethanolamine, Trisodium EDTA, Vetivera Zinzanoids (Khus Root) Extract, Water/Aqua, Withania Somniferia (Winter Cherry) Extract, Zingiber Officinale (Ginger) Extract.

PRINCIPAL DISPLAY PANEL

Jafra Sun

Face and Body Sunscreen Spray

Broad Spectrum SPF 35

UVA/UVB SPF 35

Cont. Net. 125 ml 4.2 Fl Oz

INGREDIENTS AND APPEARANCE

FACE AND BODY SUNSCREEN SPF 35  JAFRA
avobenzone, homosalate, octisalate, octocrylene, oxybenzone spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-166
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	2.79 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)
LEVOMENOL (UNII: 24WE03BX2T)
SHEA BUTTER (UNII: K49155WL9Y)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DMDM HYDANTOIN (UNII: BYR0546TOW)
GLYCERIN (UNII: PDC6A3C0OX)
LICORICE (UNII: 61ZBX54883)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
THERMUS THERMOPHILUS LYSATE (UNII: 775R692494)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
TROLAMINE (UNII: 9O3K93S3TK)
EDETATE TRISODIUM (UNII: 420IP921MB)
WATER (UNII: 059QF0KO0R)
CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)
GINGER (UNII: C5529G5JPQ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-166-02	1 in 1 CARTON	01/10/2013
1	NDC: 68828-166-01	125 mL in 1 BOTTLE; 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	01/10/2013

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(68828-166)