Label: FACE AND BODY SUNSCREEN SPRAY SPF 35- homosalate, oxybenzone, octinoxate, octisalate, octocrylene lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 68828-092-01 - Packager: Jafra Cosmetics International Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not 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 June 5, 2012
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ACTIVE INGREDIENT
Sunscreen active ingredients (SPF 35):
Homosalate, Octinoxate/Ethylhexyl Methoxycinnamate , Oxybenzone/Benzophenone-3, Octisalate/Ethylhexyl Salicylate, Octocrylene
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 before exposure. Re-apply frequently to maintain protection, especially after perspiring, swimming, or toweling.
Other Ingredients:
Water/Aqua, Acrylates Copolymer, Glycerin, Thermus Thermophillus Ferment, Polysorbate 20, Sorbitan Oleate, DMDM Hydantoin, Cetearyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Trethanolamine, Glycyrrhiza Glabra (Licorice) Extract, Moringa Oliefera Extract, Vetivera Zinzanoids (Khus Root) Extract, Withania Somnifera (winter Cherry) Extract, Panthenol, Phenoxyethanol, Hexylene Glycol, Caprylyl Glycol, Potassium Sorbate, Trisodium EDTA, Tocopheryl Acetate, Butyrospermum Parkii (Shea Butter) Fruit, Zingiber Officinale (Ginger) Extract, Bisabolol, Butylene Glycol, Pentylene Glycol, Propamidobenzoic Acid.
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
FACE AND BODY SUNSCREEN SPRAY SPF 35
homosalate, oxybenzone, octinoxate, octisalate, octocrylene lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:68828-092 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 mL in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 3 mL in 100 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 6 mL in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mL in 100 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 2.79 mL in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 20 (UNII: 7T1F30V5YH) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) DMDM HYDANTOIN (UNII: BYR0546TOW) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) (UNII: 59TL3WG5CO) TROLAMINE (UNII: 9O3K93S3TK) GLYCYRRHIZA GLABRA (UNII: 2788Z9758H) MORINGA OLEIFERA BARK (UNII: 1X2218R709) WITHANIA SOMNIFERA ROOT (UNII: V038D626IF) PANTHENOL (UNII: WV9CM0O67Z) PHENOXYETHANOL (UNII: HIE492ZZ3T) HEXYLENE GLYCOL (UNII: KEH0A3F75J) CAPRYLYL GLYCOL (UNII: 00YIU5438U) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) EDETATE TRISODIUM (UNII: 420IP921MB) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) SHEANUT OIL (UNII: O88E196QRF) GINGER (UNII: C5529G5JPQ) LEVOMENOL (UNII: 24WE03BX2T) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) PENTYLENE GLYCOL (UNII: 50C1307PZG) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:68828-092-01 1 in 1 BOX 1 125 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 06/05/2012 Labeler - Jafra Cosmetics International Inc (041676479) Registrant - Jafra Cosmetics International Inc (041676479) Establishment Name Address ID/FEI Business Operations Jafra Manufacturing, S.A. de C.V. 814732061 manufacture
