Label: FLESH HYDRATING SPF SERUM- avobenzone, homosalate, octisalate lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 10967-660-01 - Packager: Revlon Consumer Products Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
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Drug Label Information
Updated April 1, 2020
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INGREDIENTS AND APPEARANCE
FLESH HYDRATING SPF SERUM
avobenzone, homosalate, octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:10967-660 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 mg in 1 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mg in 1 mL AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 3 mg in 1 mL Inactive Ingredients Ingredient Name Strength BUTYLENE GLYCOL (UNII: 3XUS85K0RA) GLYCERIN (UNII: PDC6A3C0OX) HONEY (UNII: Y9H1V576FH) AMMONIUM ACRYLOYLDIMETHYLTAURATE/BEHENETH-25 METHACRYLATE CROSSPOLYMER (52000 MPA.S) (UNII: LZ291VH90H) CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) UREA (UNII: 8W8T17847W) HYDROXYCITRONELLAL (UNII: 8SQ0VA4YUR) LINALOOL, (+)- (UNII: F4VNO44C09) PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D) SODIUM LACTATE (UNII: TU7HW0W0QT) ORNITHINE HYDROCHLORIDE (UNII: HBK84K66XH) TROLAMINE (UNII: 9O3K93S3TK) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) LIMONENE, (+)- (UNII: GFD7C86Q1W) WATER (UNII: 059QF0KO0R) ARGININE HYDROCHLORIDE (UNII: F7LTH1E20Y) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) HYDROXYACETOPHENONE (UNII: G1L3HT4CMH) DIPROPYLENE GLYCOL (UNII: E107L85C40) LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM) MALTODEXTRIN (UNII: 7CVR7L4A2D) CHLORPHENESIN (UNII: I670DAL4SZ) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10967-660-01 30 mL in 1 PACKAGE; Type 0: Not a Combination Product 04/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 04/01/2020 Labeler - Revlon Consumer Products Corporation (788820165) Establishment Name Address ID/FEI Business Operations Englewood Lab, Inc. 080366903 manufacture(10967-660)