SUNSCREEN SPF 30 JAFRA SUN- homosalate, octisalate, octocrylene, oxybenzone, avobenzone cream

Sunscreen SPF 30 by

Drug Labeling and Warnings

Sunscreen SPF 30 by is a Otc medication manufactured, distributed, or labeled by JAFRA COSMETICS INTERNATIONAL , JAFRA COSMETICS INTERNATIONAL, Jafra Manufacturing, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Sunscreen Active Ingredients (SPF 30):Homosalate, Octisalate/Ethylhexyl Salicylate , Octocrylene, Oxybenzone/Bezophenone-3, Butyl Methoxydibenzoylmethane/Avobenzone

Purpose: Sunscreen

Keep out of reach of children

Discontinue 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 20 minutes before exposure. Re-apply frequently to maintain protection especially after perspiring, swimming or toweling.

Other Ingredients

Water/Aqua, Octyldodecanol Neopentanoate, Glyceryl Stearate, Bisabolol, Adipic Acid/Diethylene Glycol/Glycerin Crosspolymer, Potassium Cetyl Phosphate, Glycerin, Tricontanyl PVP, Caprylyl Glycol, Hexylene Glycol, Methylisothiozolinone, Polyester-8, Cetyl Dimethicone, Dimethicone, Tocopheryl Acetate, Allantoin, Xanthan Gum, Trisodium EDTA, Fragrance/Parfum [fragrance/parfum contains: Eugenol, Limonene, Linalool]

PRINCIPAL DISPLAY PANEL

Jafra Sun  30


Sunscreen Cream SPF 30
Advanced UVA/UVB Protection

Crema Bloqueadora FPS 30
Protection Avanzada
contra rayos UVA/UVB


125ml 4.2 fl oz (US)

INGREDIENTS AND APPEARANCE

SUNSCREEN SPF 30  JAFRA SUN
homosalate, octisalate, octocrylene, oxybenzone, avobenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-094
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7.5 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2.79 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
LEVOMENOL (UNII: 24WE03BX2T)
ADIPIC ACID (UNII: 76A0JE0FKJ)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERIN (UNII: PDC6A3C0OX)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P)
DIMETHICONE (UNII: 92RU3N3Y1O)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-094-01	1 in 1 CARTON	05/31/2012
1		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	05/31/2012

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(68828-094)