Label: 21STAY A THERA SUN BLOCK- octinoxate, zinc oxide, titanium dioxide, octisalate, homosalate cream

  • 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 November 21, 2017

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

  • ACTIVE INGREDIENT

    Octinoxate 6.00%
    Zinc Oxide 5.82%
    Titanium Dioxide 5.46%
    Octisalate 4.00%
    Homosalate 2.00%

  • PURPOSE

    Sunscreen

  • INDICATIONS & USAGE

    Helps prevent sunburn

  • DOSAGE & ADMINISTRATION

    Apply liberally 15 minutes before sun exposure. Reapply at least every two 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 of 15 of higher and other sun protection measures including: 1) Limited time in the sun, especially from 10 am to 2 pm. 2) Wear long-sleeve shirts, pants, hats, and sunglasses
    Ask a doctor to use for children under 6 months


  • 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 using and ask a doctor if rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of the children. If product is swallowed, get medical help or contact a poison control center right away.

  • INACTIVE INGREDIENT

    Water, Cyclopentasiloxane, Glycerin, PEG-10 Dimethicone, Dicaprylyl Ether, Polymethyl Methacrylate, Dimethicone, Silica, Disteardimonium Hectorite, Sodium Chloride, Aluminum Hydroxide, Salvia Hispanica Seed Extract, Centella Asiatica Extract, Houttuynia Cordata Extract, 1,2-Hexanediol, Bis-Ethylhexyloxyphenol, Polymethylsilsesquioxane, Stearic Acid, Fragrance, Phenoxyethanol, Dimethicone/Vinyl DimethiconeCrosspolymer, Sorbitan Sesquioleate, Dimethicone/Methicone Copolymer, Propanediol, Ethylhexylglycerin, Butylene Glycol, Octyldodecanol, Bambusa Vulgaris Extract, Echium Plantagineum Seed Oil, Helianthus Annuus (Sunflower) Seed Oil, Cardiospermum HalicacabumFlower/Leaf/Vine Extract, Lepidium Meyenii Root Extract, Vitis Vinifera (Grape) Seed Oil, Tocopherol, Vegetable Oil, Camellia Sinensis Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Extract, Maltodextrin

  • OTHER SAFETY INFORMATION

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

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    21STAY A THERA SUN BLOCK 
    octinoxate, zinc oxide, titanium dioxide, octisalate, homosalate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71883-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE60 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION58.2 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE54.6 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 mL
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PEG-10 DIMETHICONE (600 CST) (UNII: 8PR7V1SVM0)  
    Dicaprylyl Ether (UNII: 77JZM5516Z)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0)  
    CHIA SEED (UNII: NU0OLX06F8)  
    CENTELLA ASIATICA (UNII: 7M867G6T1U)  
    HOUTTUYNIA CORDATA FLOWERING TOP (UNII: RH041UUZ22)  
    1,2-Hexanediol (UNII: TR046Y3K1G)  
    BEMOTRIZINOL (UNII: PWZ1720CBH)  
    POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)  
    Sorbitan Sesquioleate (UNII: 0W8RRI5W5A)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Octyldodecanol (UNII: 461N1O614Y)  
    BAMBUSA VULGARIS TOP (UNII: FIW80T6P6V)  
    ECHIUM PLANTAGINEUM SEED OIL (UNII: PIB7XBU8XW)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    CARDIOSPERMUM HALICACABUM FLOWERING TOP (UNII: MZP2508BRR)  
    LEPIDIUM MEYENII ROOT (UNII: HP7119212T)  
    GRAPE SEED OIL (UNII: 930MLC8XGG)  
    Tocopherol (UNII: R0ZB2556P8)  
    CORN OIL (UNII: 8470G57WFM)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    SAGE (UNII: 065C5D077J)  
    MELALEUCA ALTERNIFOLIA LEAF (UNII: G43C57162K)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71883-001-021 in 1 CARTON11/21/2017
    1NDC:71883-001-0140 mL in 1 CONTAINER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/21/2017
    Labeler - Oracle Cosmetic Co., Ltd. (688258270)
    Registrant - Oracle Cosmetic Co., Ltd. (688258270)
    Establishment
    NameAddressID/FEIBusiness Operations
    COSON Co., Ltd._Osan Plant689847210manufacture(71883-001)