Label: SUNSCREEN- homosalate, octinoxate, octisalate, oxybenzone lotion
- NDC Code(s): 61010-6103-0, 61010-6103-1, 61010-6103-2, 61010-6103-3
- Packager: Safetec of America, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated February 8, 2024
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INGREDIENTS AND APPEARANCE
SUNSCREEN
homosalate, octinoxate, octisalate, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61010-6103 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 6 mg in 1 g OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 7.5 mg in 1 g OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 mg in 1 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 5 mg in 1 g Inactive Ingredients Ingredient Name Strength CETYL ALCOHOL (UNII: 936JST6JCN) POVIDONE K30 (UNII: U725QWY32X) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLPARABEN (UNII: A2I8C7HI9T) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) POLYOXYL 40 STEARATE (UNII: 13A4J4NH9I) POLYSORBATE 60 (UNII: CAL22UVI4M) PETROLATUM (UNII: 4T6H12BN9U) WATER (UNII: 059QF0KO0R) SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X) EDETATE SODIUM (UNII: MP1J8420LU) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) XANTHAN GUM (UNII: TTV12P4NEE) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) DIMETHICONE (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61010-6103-1 25 in 1 BOX 03/13/2007 1 NDC:61010-6103-0 3.5 g in 1 PACKET; Type 0: Not a Combination Product 2 NDC:61010-6103-3 25 in 1 BOX 07/01/2018 2 NDC:61010-6103-2 2 g in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M020 03/13/2007 Labeler - Safetec of America, Inc. (874965262) Establishment Name Address ID/FEI Business Operations Safetec of America, Inc. 874965262 manufacture(61010-6103)