Label: SPF 50 MOISTURIZING SUNSCREEN BROAD SPECTRUM- octinoxate, zinc oxide 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 November 30, 2022

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  • ACTIVE INGREDIENT

    Active Ingredients                            Purpose

    Octinoxate 6%, Zinc Oxide 12%       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 liberally 15 minutes before sun exposure

    • Reapplyat least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating
    • 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 15 or higher and other sun protection measures including:
    • Limit time in the sun, especially from 10a.m. – 2p.m.
    • Wear long-sleeve shirts, pants, hats, and sunglasses
    • Children under six months consult a physician

  • INACTIVE INGREDIENT

    Inactive ingredients   ​ ​Water, Polysorbate 60, Coconut Alkanes, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Cetearyl Alcohol, Glycerin, Cyclopentasiloxane, Glyceryl Stearate, PEG-100 Stearate, Bisabolol, Coffea Arabica (Coffee) Seed Oil, Pentylene Glycol, Tetrahexyldecyl Ascorbate, Xanthophyll, Ascorbyl Palmitate, Tocopherol, Beta-Carotene, Coco-Caprylate/Caprate, Folic Acid, Carthamus Tinctorius (Saffower) Seed Oil, Solanum Lycopersicum (Tomato) Seed Oil, Tocopheryl Acetate, Vaccinium Myrtillus (Bilberry) Fruit Extract, Argania Spinosa Kernel Oil, Dimethicone, Dipotassium Phosphate, Hydrogenated Lecithin, Potassium Phosphate, Zea Mays (Corn) Oil, Polyhydroxystearic Acid, Alcohol, Butylene Glycol, Xanthan Gum, Disodium EDTA, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Citric Acid, Dehydroacetic Acid, Benzyl Alcohol

  • PRINCIPAL DISPLAY PANEL

    SPF 50+

    Moisturizing Sunscreen

    Broad Spectrum Daily Use

    1Fl Oz/30 mL

    Tube 1 oz

  • INGREDIENTS AND APPEARANCE
    SPF 50 MOISTURIZING SUNSCREEN BROAD SPECTRUM 
    octinoxate, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72274-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE6 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE12 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    ARABICA COFFEE OIL (UNII: IK55HKE887)  
    PENTYLENE GLYCOL (UNII: 50C1307PZG)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    LUTEIN (UNII: X72A60C9MT)  
    ASCORBYL PALMITATE (UNII: QN83US2B0N)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    .BETA.-CAROTENE (UNII: 01YAE03M7J)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    FOLIC ACID (UNII: 935E97BOY8)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    TOMATO SEED OIL (UNII: 7N87T9C06T)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BILBERRY (UNII: 9P2U39H18W)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DIBASIC POTASSIUM PHOSPHATE (UNII: CI71S98N1Z)  
    HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)  
    POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)  
    CORN OIL (UNII: 8470G57WFM)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    ALCOHOL (UNII: 3K9958V90M)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72274-002-0130 mL in 1 TUBE; Type 0: Not a Combination Product05/04/2018
    2NDC:72274-002-0290 mL in 1 TUBE; Type 0: Not a Combination Product05/04/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35205/04/2018
    Labeler - GATE THERAPEUTICS (081159085)
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