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

  • 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 January 26, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • ACTIVE INGREDIENTS

    Avobenzone 2%

    Homosalate 10%

    Octinoxate 5%

    Octisalate 5%

  • PURPOSE

    SUNSCREEN

  • 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
  • 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. Stop use and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • 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 early skin aging. To decrease this risk,

    regularly use a sunscreen with a Broad Spectrum SPF 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 INGREDIENTS

    Water, Dihydroxyacetone, Diethylhexyl Carbonate, Propanediol, Saccharomyces Ferment, Styrene/Acrylates Copolymer, Trimethylpentanediol/Adipic Acid Copolymer, Ceteareth-25, Glyceryl Stearate, Glyceryl Caprylate, Cetearyl Alcohol, Polyester-7, Microcrystalline Cellulose, Disodium Ethylene Dicocamide PEG-15 Disulfate, Panthenol, Neopentyl Glycol Diheptanoate, Diethylhexyl Syringylidenemalonate, Sodium Metabisulfite, Chlorphenesin, Citrus Aurantium Dulcis (Orange) Peel Extract, Sodium Lauroyl Glutamate, Stearic Acid, Tocopherol, Cellulose Gum, Aloe Barbadensis Leaf Juice, Citric Acid, Glyceryl Undecylenate, Caprylic/Capric Triglyceride

  • OTHER INFORMATION

    Protect the product in this container from excessive heat and direct sun

  • QUESTIONS OR COMMENTS?

    Contact our Sun Specialists 877-564-7330

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Sunless Tan SPF 40_100mL

  • INGREDIENTS AND APPEARANCE
    HEALTHY GLOW SUNLESS TAN BROAD SPECTRUM SUNSCREEN  SPF 40
    avobenzone, homosalate, octinoxate, octisalate spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-514
    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
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    ORANGE PEEL (UNII: TI9T76XD44)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    WATER (UNII: 059QF0KO0R)  
    DIHYDROXYACETONE (UNII: O10DDW6JOO)  
    DIETHYLHEXYL CARBONATE (UNII: YCD50O0Z6L)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    SACCHAROMYCES LYSATE (UNII: R85W246Z1C)  
    STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)  
    TRIMETHYLPENTANEDIOL/ADIPIC ACID/GLYCERIN CROSSPOLYMER (25000 MPA.S) (UNII: 587WKM3S9Q)  
    CETEARETH-25 (UNII: 8FA93U5T67)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYESTER-7 (UNII: 0841698D2F)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    DISODIUM ETHYLENE DICOCAMIDE PEG-15 DISULFATE (UNII: QI9A6U005W)  
    SODIUM LAUROYL GLUTAMATE (UNII: NCX1UU2D33)  
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-514-34100 mL in 1 BOTTLE; Type 0: Not a Combination Product01/26/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02001/26/2023
    Labeler - Supergoop, LLC (117061743)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!