Label: JAFRA SUN BODY PROTECTOR SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene cream
- NDC Code(s): 68828-294-01, 68828-294-02
- Packager: Jafra Cosmetics International
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 2, 2024
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- Uses
- KEEP OUT OF REACH OF CHILDREN
- Warnings
-
Directions
- apply liberally and evenly 15 minutes before sun exposure
- Reapply:
• 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-sleeved shirts, pants, hats, and sunglasses
- Other Information
-
Inactive Ingredients
Water, Polyester-8, Glyceryl Stearate, PEG-100 Stearate, Styrene/Acrylates Copolymer, Cetyl Alcohol, Dicaprylyl Carbonate, VP/Eicosene Copolymer, Ethylhexyl Methoxycrylene, Phenoxyethanol, Ethylhexylglycerin, Mica, Silica, Arginine, Glycerin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopheryl Acetate, Fragrance/Parfum, Disodium EDTA, Panthenol, Bisabolol, Sambucus Nigra (Elderberry) Fruit Extract, Benzyl Salicylate, Butylphenyl Methylpropional, Coumarin, Hydroxycitronellal, Linalool, Limonene
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INGREDIENTS AND APPEARANCE
JAFRA SUN BODY PROTECTOR SUNSCREEN BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-294 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 OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 10 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) GLYCERIN (UNII: PDC6A3C0OX) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED) (UNII: T9296U138P) EUROPEAN ELDERBERRY (UNII: BQY1UBX046) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) WATER (UNII: 059QF0KO0R) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) PEG-100 STEARATE (UNII: YD01N1999R) PANTHENOL (UNII: WV9CM0O67Z) ARGININE (UNII: 94ZLA3W45F) CETYL ALCOHOL (UNII: 936JST6JCN) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) MICA (UNII: V8A1AW0880) ETHYLHEXYL METHOXYCRYLENE (UNII: S3KFG6Q5X8) STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A) LEVOMENOL (UNII: 24WE03BX2T) DICAPRYLYL CARBONATE (UNII: 609A3V1SUA) BENZYL SALICYLATE (UNII: WAO5MNK9TU) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) COUMARIN (UNII: A4VZ22K1WT) HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) LIMONENE, (+)- (UNII: GFD7C86Q1W) LINALOOL, (+/-)- (UNII: D81QY6I88E) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-294-01 125 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/14/2021 2 NDC:68828-294-02 7.5 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/14/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 01/14/2021 Labeler - Jafra Cosmetics International (041676479) Establishment Name Address ID/FEI Business Operations Distribuidora Comercial Jafra, S.A. de C.V. 951612777 manufacture(68828-294)
