Label: SUNBETTER BROAD SPECTRUM SPF 75 SUNSCREEN TONE SMART- zinc oxide, titanium dioxide lotion
- NDC Code(s): 62282-376-01, 62282-376-02, 62282-376-03, 62282-376-04
- Packager: Northwest Cosmetic Laboratories LLC, D.B.A. Elevation Labs Idaho
- Category: HUMAN OTC DRUG LABEL
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Drug Label Information
Updated November 3, 2022
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INGREDIENTS AND APPEARANCE
SUNBETTER BROAD SPECTRUM SPF 75 SUNSCREEN TONE SMART
zinc oxide, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62282-376 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 35 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 100 mg in 1 mL Inactive Ingredients Ingredient Name Strength SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CHLORIDE (UNII: 451W47IQ8X) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) GINGER (UNII: C5529G5JPQ) ALLANTOIN (UNII: 344S277G0Z) ALUMINUM OXIDE (UNII: LMI26O6933) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) TRIETHYL CITRATE (UNII: 8Z96QXD6UM) UBIDECARENONE (UNII: EJ27X76M46) WATER (UNII: 059QF0KO0R) STARCH, CORN (UNII: O8232NY3SJ) DODECAMETHYLPENTASILOXANE (UNII: 0QDQ2VQ5YJ) OPUNTIA FICUS-INDICA STEM (UNII: MUD8892KHL) PHENYLETHYL ALCOHOL (UNII: ML9LGA7468) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) SQUALANE (UNII: GW89575KF9) STEARIC ACID (UNII: 4ELV7Z65AP) CETYL DIMETHICONE 45 (UNII: IK315POC44) .ALPHA.-BISABOLOL, (+/-)- (UNII: 36HQN158VC) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) CAPER BERRY (UNII: 7G4C45EE8C) CERIC OXIDE (UNII: 619G5K328Y) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) HIMANTHALIA ELONGATA (UNII: 21RND18XRR) MICA (UNII: V8A1AW0880) DIMETHICONE (UNII: 92RU3N3Y1O) GLYCERIN (UNII: PDC6A3C0OX) FERRIC OXIDE RED (UNII: 1K09F3G675) NIACINAMIDE (UNII: 25X51I8RD4) BLACK OLIVE (UNII: 2M6QWV94OC) OLEA EUROPAEA LEAF (UNII: MJ95C3OH47) PANTHENOL (UNII: WV9CM0O67Z) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) POLYGLYCERYL-4 OLEATE (UNII: 15B05TY4GX) POLYGONUM AVICULARE TOP (UNII: ZCD6009IUF) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) TROPOLONE (UNII: 7L6DL16P1T) 1,2-HEXANEDIOL (UNII: TR046Y3K1G) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62282-376-01 1 in 1 CARTON 02/02/2021 1 50 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 2 NDC:62282-376-02 15 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 02/01/2021 3 NDC:62282-376-03 1 mL in 1 PACKET; Type 0: Not a Combination Product 02/01/2021 4 NDC:62282-376-04 237 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 02/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 02/01/2021 Labeler - Northwest Cosmetic Laboratories LLC, D.B.A. Elevation Labs Idaho (929572014)