Label: LIP SCREEN BROAD SPECTRUM SPF 40- avobenzone, homosalate, octisalate, octocrylene liquid

  • 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 July 11, 2023

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

  • ACTIVE INGREDIENT

    Avobenzone 3% Sunscreen

    Homosalate 5% Sunscreen

    Octisalate 5% Sunscreen

    Octocrylene 10% Sunscreen

  • 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
    Use a water-resistant sunscreen if swimming or sweating
    Reapply 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 your time in the sun, especially from 10
    a.m. – 2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses •
    Children under 6 months of age: ask a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Hydrogenated Polyisobutene, Diisostearyl Malate, Caprylic/Capric Triglyceride, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Polyurethane-79, Polyester-7, Butyrospermum Parkii (Shea) Butter, Cocos Nucifera (Coconut) Oil, Isopropyl Palmitate , Sesamum Inidicum (Sesame) Seed Oil, Neopentyl Glycol Diheptanoate, Diethylhexyl Syringlidenemalonate, Caprylyl Glycol, Glycine Soja (Soybean) Oil, Tocopherol, 2-Methylbutyric Acid, Barosma Betulina Leaf Oil, Benzaldehyde, Dimethylhydroxy Furanone, Trans-2-Hexenal, Helianthus Annuus (Sunflower) Seed Oil, Ethyl Acetate, Stevioside, Gamma-Undecalactone, Vanillin, Vitis Vinifera (Grape) Seed Extract, Laminaria Ochroleuca Extract, Citric Acid

  • PRINCIPAL DISPLAY PANEL

    Lip Screen

    SPF 40

    Broad Spectrum SPF 40

    0.34 fl. oz. / 10 ml.

    CartonTube

  • INGREDIENTS AND APPEARANCE
    LIP SCREEN BROAD SPECTRUM SPF 40 
    avobenzone, homosalate, octisalate, octocrylene liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75936-257
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ETHYL ACETATE (UNII: 76845O8NMZ)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLYESTER-7 (UNII: 0841698D2F)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    DIMETHYLHYDROXY FURANONE (UNII: 20PI8YZP7A)  
    2-HEXENAL, (2E)- (UNII: 69JX3AIR1I)  
    DIETHYLHEXYL SYRINGYLIDENEMALONATE (UNII: 3V5U97P248)  
    LAMINARIA OCHROLEUCA (UNII: 4R2124HE76)  
    AGATHOSMA BETULINA LEAF OIL (UNII: KOS935A04V)  
    VANILLIN (UNII: CHI530446X)  
    2-METHYLBUTYRIC ACID (UNII: PX7ZNN5GXK)  
    SESAME OIL (UNII: QX10HYY4QV)  
    .GAMMA.-UNDECALACTONE (UNII: QB1T0AG2YL)  
    DIISOSTEARYL MALATE (UNII: QBS8A3XZGQ)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    STEVIOSIDE (UNII: 0YON5MXJ9P)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    BENZALDEHYDE (UNII: TA269SD04T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75936-257-0110 mL in 1 TUBE; Type 0: Not a Combination Product04/22/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/22/2020
    Labeler - Supergoop, LLC (117061743)