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

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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Active Sport Family sunscreen Cream SPF 35

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.

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



image of tube art

ACTIVE SPORT  FAMILY SUNSCREEN SPF 35
octinoxate, octisalate, avobenzone, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68828-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE9.375 g  in 125 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE6.25 g  in 125 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2.5 g  in 125 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE1.875 g  in 125 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68828-103-01125 mL in 1 TUBE; Type 0: Not a Combination Product05/15/201201/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35205/15/201201/01/2021
Labeler - JAFRA COSMETICS INTERNATIONAL (041676479)
Registrant - JAFRA COSMETICS INTERNATIONAL (041676479)
Establishment
NameAddressID/FEIBusiness Operations
Jafra Manufacturing, S.A. de C.V.814732061manufacture(68828-103)

Revised: 1/2021
 
JAFRA COSMETICS INTERNATIONAL