Label: HEALTHY GLOW SUNLESS TAN BROAD SPECTRUM SPF 40- avobenzone, homosalate, octinoxate, octisalate lotion
- NDC Code(s): 75936-143-01
- Packager: Supergoop LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 April 8, 2023
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
Directions
- apply generously and evenly 15 minutes before sun exposure
reapply:
- after 80 minutes of swimming or sweating
- immediately after towel drying
- at least every 2 hours
- Sun Protection Measures Spending time in the sun increases your risk of skin cancer and eartl skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum value of 15 or higher and other sun protection measures including:
- Limit time in the sun, especially from 10 a.m.-2 p.m.
- Wear long-sleeved shirts, pants, hats, and sunglasses
- Children under 6 months: ask a doctor
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INACTIVE INGREDIENT
Inactive Ingredients: Water, Aloe Barbadensis Leaf Juice, Dihydroxyacetone, Diethylhexyl Carbonate, Butyloctyl Salicylate, Propanediol, Styrene/Acrylates Copolymer, Trimethylpentanediol/adipic Acid Copolymer, Saccharomyces, Ferment, Ceteareth-25, Glyceryl Caprylate, Polyester-7, Disodium Ethylene Diocamide PEG-15 Disulfate, Glyceryl Stearate, Cetearyl Alcohol, Diethylhexyl Syringylidenemalonate, Citrus Aurantium Dulcis (orange) Peel extract, Neopentyl Glycol Diheptanoate, Sodium Metabisulfsite, Microcrystalline Cellulose, Stearic Acid, Sodium Lauryl Glutamate, Chlorphenesin, Cellulose Gum, Panthenol, Glyceryl Undecylenate, Caprylic/Capric Triglyceride, Tocopheryl Acetate, Citric Acid
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
HEALTHY GLOW SUNLESS TAN BROAD SPECTRUM SPF 40
avobenzone, homosalate, octinoxate, octisalate lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:75936-143 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 2 g in 100 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 10 g in 100 mL OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 5 g in 100 mL OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE 5 g in 100 mL Inactive Ingredients Ingredient Name Strength MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) ALOE VERA LEAF (UNII: ZY81Z83H0X) DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248) SODIUM METABISULFITE (UNII: 4VON5FNS3C) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYESTER-7 (UNII: 0841698D2F) DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) CHLORPHENESIN (UNII: I670DAL4SZ) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311) PANTHENOL (UNII: WV9CM0O67Z) GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33) ORANGE PEEL (UNII: TI9T76XD44) NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3) CETEARETH-25 (UNII: 8FA93U5T67) DIHYDROXYACETONE (UNII: O10DDW6JOO) DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L) PROPANEDIOL (UNII: 5965N8W85T) GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75936-143-01 100 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/02/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final M020 01/02/2018 Labeler - Supergoop LLC (117061743)