Label: SOLAR PROTECTION FLUID BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene cream
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-240-01, 68828-240-02, 68828-240-03 - Packager: JAFRA COSMETICS INTERNATIONAL
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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.
Drug Label Information
Updated February 5, 2018
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- INDICATIONS & USAGE
- WARNINGS
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DOSAGE & ADMINISTRATION
Directions
- apply liberally 15 minutes before sun exposure
- use a water resistant sunscreen if
- swimming or sweating
- reapply at least every 2 hours children under 6 months: Ask a doctor
- Sun Protection Measures. Spending time in the sun icreases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Specturm SPF 15 or higher and other sun protection measures including:
- limit time in the sun, especially from 10 a.m. - 2 p.m.
- Wear long-sleeve shirts, pants, hats, and sunglasses
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INACTIVE INGREDIENT
Water/Aqual, Styrene/Acrylate Copolymer, Glyceryl Stearate, PEG-100 Stearate, Aluminum Starch Octenylsuccinate, Lauroyl Lysine, Arachidyl Alcohol, Behenyl Alcohol, Arachidyl Glucoside, Ethylhexylglycerin, Benzyl Alcohol, Bisabolol, Royal Jelly, Cyclopentasiloxane, Acrylates/Dimethicon Copolymer, Cocos Nucifera, Moringa Oleifera, Fragrance/Parfum, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Allantoin, Arginine, Chlorphenesin, Cichorium Intybus (Chicory) Root Extract, Kappaphycus Alvarezii Extract, Glycerin, Polygonum Aviculare Extract, Sodium Ascorbyl Phosphate, Benzyl Salicylate, Limonene, Hydroxycitronellal, Butylphenyl Methylpropional (Lillial), Linalool
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SOLAR PROTECTION FLUID BROAD SPECTRUM SPF 50
avobenzone, homosalate, octisalate, octocrylene creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-240 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 OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-100 STEARATE (UNII: YD01N1999R) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) LAUROYL LYSINE (UNII: 113171Q70B) ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU) DOCOSANOL (UNII: 9G1OE216XY) ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ) BENZYL ALCOHOL (UNII: LKG8494WBH) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) ROYAL JELLY (UNII: L497I37F0C) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) COCOS NUCIFERA WHOLE (UNII: 245J88W96L) MORINGA OLEIFERA WHOLE (UNII: 5JH60A416W) CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO) EDETATE DISODIUM (UNII: 7FLD91C86K) ALLANTOIN (UNII: 344S277G0Z) ARGININE (UNII: 94ZLA3W45F) CHLORPHENESIN (UNII: I670DAL4SZ) CHICORY ROOT (UNII: 090CTY533N) KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O) GLYCERIN (UNII: PDC6A3C0OX) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) BENZYL SALICYLATE (UNII: WAO5MNK9TU) LIMONENE, (+/-)- (UNII: 9MC3I34447) HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) LINALOOL, (+/-)- (UNII: D81QY6I88E) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-240-02 1 in 1 BOX 08/10/2015 1 NDC:68828-240-01 50 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:68828-240-03 1 mL in 1 PACKAGE; Type 0: Not a Combination Product 02/02/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/10/2015 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(68828-240)