Label: EVERY. SINGLE. FACE. WATERY SPF 50- avobenzone, homosalate, octisalate, octocrylene lotion

  • NDC Code(s): 75936-360-01, 75936-360-02, 75936-360-03
  • 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 October 19, 2022

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Avobenzone 3% Sunscreen

    Homosalate 9%

    Octisalate 5%

    Octocrylene 9%

  • 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
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • 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

  • DOSAGE & ADMINISTRATION

    Directions

    • apply generously and evenly 15 minutes before sun exposure

    reapply:

    • after 40 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 early skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF calue of 15 or higher and other sun protection measures including:

    • Limit time in the sun, especially from 10 a.m.-2p.m.
    • Wear long-sleeved shirts, pants, hats, and sunglasses
    • Reapply at least every 2 hours
    • Children under 6 months: Ask a doctor
  • INACTIVE INGREDIENT

    Inactive Ingredients Water, Alcohol, C12-15 Alkyl Benzoate, Propanediol, Dimethicone, Glycerin, Acrylates/Polytrimethylsiloxymethacrylate Copolymer, Maltodextrin, Triethyl Citrate, Hydroxyacetophenone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, 1,2-Hexanediol, Caprylyl Glycol, Pullulan, Sodium Polyacrylate, Betaine, Lavandula Angustifolia (Lavender) Flower/Leaf/Stem Extract, Tremella Fuciformis Sporocarp Extract, Amyl Cinnamal, Glyceryl Caprylyl, Glyceryl Undecylenate, Sodium Carboxymethyl Beta-Glucan, Pyrus Malus (Apple) Fruit Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Rubus Idaeus (Raspberry) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Lepidium Sativum Sprout Extract

  • OTHER SAFETY INFORMATION

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

  • PRINCIPAL DISPLAY PANEL

    Supergoop!

    EVERY. SINGLE. FACE.

    WATERY LOTION

    SPF 50

    Broad Spectrum Sunscreen SPF 50 PA++++

    Water & Sweat Resistant (40 minutes)

    1.7 fl. oz./ 50 ml.

    50 ml carton

    50 ml bottle

  • INGREDIENTS AND APPEARANCE
    EVERY. SINGLE. FACE. WATERY SPF 50 
    avobenzone, homosalate, octisalate, octocrylene lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-360
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE9 g  in 100 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE9 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    TREMELLA FUCIFORMIS FRUITING BODY (UNII: GG8N28393G)  
    .ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418)  
    SAGE (UNII: 065C5D077J)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    PULLULAN (UNII: 8ZQ0AYU1TT)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    RUBUS IDAEUS LEAF (UNII: 8O2V33JG64)  
    GARDEN CRESS SPROUT (UNII: PWQ18YNR62)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ROSEMARY (UNII: IJ67X351P9)  
    GLYCERYL MONOCAPRYLATE (UNII: TM2TZD4G4A)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SODIUM CARBOXYMETHYL .BETA.-GLUCAN (DS 0.65-0.85) (UNII: 2YGO1190AP)  
    LAVANDULA ANGUSTIFOLIA SUBSP. ANGUSTIFOLIA FLOWERING TOP (UNII: 9YT4B71U8P)  
    HEDYCHIUM CORONARIUM ROOT (UNII: 92A6N0IQN9)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    SODIUM POLYACRYLATE (8000 MW) (UNII: 285CYO341L)  
    WATER (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    APPLE (UNII: B423VGH5S9)  
    BETAINE (UNII: 3SCV180C9W)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-360-011.5 mL in 1 PACKET; Type 0: Not a Combination Product01/15/2022
    2NDC:75936-360-0210 mL in 1 TUBE; Type 0: Not a Combination Product01/15/2022
    3NDC:75936-360-0350 mL in 1 BOTTLE; Type 0: Not a Combination Product11/11/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/11/2021
    Labeler - Supergoop, LLC (117061743)
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