Label: SUNSCREEN- homosalate, octinoxate, zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 19, 2021

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  • Active Ingredients

    Homosalate 15%

    Octisalate 5%

    Zinc Oxide 4%

  • 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
  • Warnings

    For external use only

  • Do not use

    On damaged or broken skin

  • Ask a doctor

    Stop use and ask a doctor if rash develops

  • When Using

    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. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally 15 minutes before sun exposure
    • reapply: use a water resistant sunscreen if swimming or sweating
    • immediately after towel drying
    • at least every 2 hours
    • children under 6 months: ask a doctor
  • Other Information

    • Protect this product from excessive heat and direct sun
    • may stain some fabrics
  • Inactive Ingredients

    Water (Aqua), Glycerin, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Polyacrylamide, Cetearyl Alcohol, Phenoxyethanol, C13-14 Isoparaffin, Caprylyl Glycol, Cyclotetrasiloxane, Lauroyl Lysine, Ethylhexylglycerin, Polyhydroxystearic Acid, Hexylene Glycol, Laureth-7, Allantoin, Dimethiconde/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Triethoxycaprylylsilane.

  • Questions or Comments?

    1-833-906-2662 Monday - Friday 9AM-5PM MST

  • PRINCIPAL DISPLAY PANEL

    28032

    SPF 15 Face Lotion NDC: 81757-001-04

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN 
    homosalate, octinoxate, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81757-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)  
    OCTAMETHYLTETRASILOXANE (UNII: YB15PH50RH)  
    LAURETH-7 (UNII: Z95S6G8201)  
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    ALLANTOIN (UNII: 344S277G0Z)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    LAUROYL LYSINE (UNII: 113171Q70B)  
    CYCLOMETHICONE (UNII: NMQ347994Z)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81757-001-04118 mL in 1 TUBE; Type 0: Not a Combination Product04/13/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35204/13/2021
    Labeler - Imperfect Foods (109460818)
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