Label: HEALTHY GLOW SUNLESS TAN BROAD SPECTRUM SPF 40- avobenzone, homosalate, octinoxate, octisalate lotion

  • 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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  • ACTIVE INGREDIENT

    Active ingredients Purpose

    Avobenzone 2% Sunscreen

    Homosalate 10%

    Octinoxate 5%

    Octisalate 5%

  • PURPOSE

    Uses

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
  • INDICATIONS & USAGE

    Stop use and ask a doctor if rash occurs.

  • WARNINGS

    Warnings

    For external use only. Do not use ​on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove.

  • KEEP OUT OF REACH OF CHILDREN

    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
  • 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

    Healthy Glow

    Sunless Tan Broad Spectrum SPF 40

    Supergoop!

    3.4 fl. oz./ 100 mL

    Bottle

  • INGREDIENTS AND APPEARANCE
    HEALTHY GLOW SUNLESS TAN BROAD SPECTRUM SPF 40 
    avobenzone, homosalate, octinoxate, octisalate lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-143
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE2 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE10 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE5 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-143-01100 mL in 1 BOTTLE; Type 0: Not a Combination Product01/02/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02001/02/2018
    Labeler - Supergoop LLC (117061743)
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