ACTIVE SPORT FAMILY SUNSCREEN SPF 35- octinoxate, octisalate, avobenzone, octocrylene cream

Active Sport by

Drug Labeling and Warnings

Active Sport 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

Sunscreen Active Ingredients (SPF 35): Octinoxate/Ethylhexyl Methoxycinnamate, Octisalate/Ethylhexyl Salicylate, Butyl Methoxydibenzoylmethane/Avobenzone, Octocrylene

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 evenly to sun-exposed areas and re-apply after prolonged water exposure or if excessive perspiring occurs.

Other ingredients: Water/Aqua, Octyldodecyl Neopentanoate, Glyceryl Stearate, Di-C12-15 Alkyl Fumurate, C12-15 Alkyl Benzoate, Stearyl Dimethicone, Adipic Acid/Diethylene Glycol/Glycerin Crosspolymer, Tricontanyl PVP, Potassium Cetyl Phosphate, Glycerin, PVP/Eicosene Copolymer, Diisostearyl Trimethylolpropane Siloxy Silicate, Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, Benzyl Alcohol, Enteromorpha Compressa Extract, Tocopheryl Acetate, Allantoin, Butylene Glycol, Cetyl Dimethicone, Xanthan Gum, Trisodium EDTA.

PRINCIPAL DISPLAY PANEL

Jafra sun
35

Active sport
Family Sunscreen Cream SPF 35

Crema Corporal Bloqueadora
FPS 35 para toda la familia
Con Proteccion Avanzada contra los Rayos UV

125 ml 4.2 Fl Oz

INGREDIENTS AND APPEARANCE

ACTIVE SPORT  FAMILY SUNSCREEN SPF 35
octinoxate, octisalate, avobenzone, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68828-103
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	9.375 g  in 125 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	6.25 g  in 125 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.5 g  in 125 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	1.875 g  in 125 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
DI-C12-15 ALKYL FUMARATE (UNII: A1CB3Z898P)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
ADIPIC ACID (UNII: 76A0JE0FKJ)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ULVA COMPRESSA (UNII: SXZ209FM33)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALLANTOIN (UNII: 344S277G0Z)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE TRISODIUM (UNII: 420IP921MB)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68828-103-01	125 mL in 1 TUBE; Type 0: Not a Combination Product	05/15/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/15/2012

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(68828-103)