Face and Body Sunscreen Spray SPF 35

FACE AND BODY SUNSCREEN SPRAY SPF 35- homosalate, oxybenzone, octinoxate, octisalate, octocrylene lotion
Jafra Cosmetics International Inc

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Sunscreen active ingredients (SPF 35):

Homosalate, Octinoxate/Ethylhexyl Methoxycinnamate , Oxybenzone/Benzophenone-3, Octisalate/Ethylhexyl Salicylate, Octocrylene

Purpose: Sunscreen

Keep out of reach of children

Discontinue use if signs of irritation appear.

Caution: For external use only. Avoid contact with eyes. Seek the advice of a physician prior to use on children under six months of age.

To use: Apply sunscreen product before exposure. Re-apply frequently to maintain protection, especially after perspiring, swimming, or toweling.

Other Ingredients:
Water/Aqua, Acrylates Copolymer, Glycerin, Thermus Thermophillus Ferment, Polysorbate 20, Sorbitan Oleate, DMDM Hydantoin, Cetearyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Trethanolamine, Glycyrrhiza Glabra (Licorice) Extract, Moringa Oliefera Extract, Vetivera Zinzanoids (Khus Root) Extract, Withania Somnifera (winter Cherry) Extract, Panthenol, Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, Trisodium EDTA, Tocopheryl Acetate, Butyrospermum Parkii (Shea Butter) Fruit, Zingiber Officinale (Ginger) Extract, Bisabolol, Butylene Glycol, Pentylene Glycol, Propamidobenzoic Acid.

Jafra Sun

Face and Body Sunscreen Spray SPF 35

Advanced UV protection

Protector Solar en Spray

Facial y Corporal FPS 35

Proteccion Avanzada

contra rayos

FACE AND BODY SUNSCREEN SPRAY SPF 35
homosalate, oxybenzone, octinoxate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:68828-092
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 mL in 100 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3 mL in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	6 mL in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mL in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.79 mL in 100 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
DMDM HYDANTOIN (UNII: BYR0546TOW)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO)
TROLAMINE (UNII: 9O3K93S3TK)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
MORINGA OLEIFERA BARK (UNII: 1X2218R709)
WITHANIA SOMNIFERA ROOT (UNII: V038D626IF)
PANTHENOL (UNII: WV9CM0O67Z)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
EDETATE TRISODIUM (UNII: 420IP921MB)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SHEANUT OIL (UNII: O88E196QRF)
GINGER (UNII: C5529G5JPQ)
LEVOMENOL (UNII: 24WE03BX2T)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PENTYLENE GLYCOL (UNII: 50C1307PZG)

#	Item Code	Package Description
Packaging
1	NDC:68828-092-01	1 in 1 BOX
1		125 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	06/05/2012

Labeler - Jafra Cosmetics International Inc (041676479)

Registrant - Jafra Cosmetics International Inc (041676479)

Name	Address	ID/FEI	Business Operations
Establishment
Jafra Manufacturing, S.A. de C.V.		814732061	manufacture