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
- 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 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)
