Label: COSRX- vitamin e vitalizing sunscreen lotion

  • Category: HUMAN OTC DRUG LABEL

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 January 9, 2023

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  • ACTIVE INGREDIENT

    Avobenzone 2.5%

    Homosalate 9.0%

    Octisalate 4.5%

    Octocrylene 9.0%

  • PURPOSE

    Sunscreen

  • WHEN USING

    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 damanged or broken skin.

    When using this product keep out of eyes. Rinse with water to remove.

    Stop use and ask a doctor if rash occurs.

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

  • DESCRIPTION

    Apply liberally 15 minutes before sun exposure
    Children under 6 months of age : Ask a doctor.
    Reapply at 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 of 15 or higher and other sun protection measures including :

    Limit time in the sun, especially from 10 a.m. - 2 p.m.

    Wear long-sleeved shirts, pants, hats, and sunglasses.

  • OTHER SAFETY INFORMATION

    Protect the product in this container from excessive heat and direct sun.
    Sun alert : Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.

  • INACTIVE INGREDIENT

    Water / Aqua / Eau, Propanediol, Butyloctyl salicylate, Diphenylsiloxy phenyl trimethicone, Dimethicone, VP/Eicosene copolymer, Silica, Trisiloxane, Cyclopentasiloxane, Trimethylsiloxysilicate, 1,2-Hexanediol, Behenyl alcohol, Glyceryl stearate, PEG-100 stearate, C14-22 alcohols, Cetyl alcohol, Potassium cetyl phosphate, Polyacrylate-13, Polyisobutene, Fragrance / Parfum, C12-20 Alkyl glucoside, Butylene glycol, Disodium EDTA, Ethylhexylglycerin, Polysorbate 20, Sorbitan isostearate, Dextrin, Theobroma cacao (cocoa) extract, Gossypium herbaceum (cotton) extract, Glucose, Tocopherol

  • QUESTIONS

    global@cosrx.co.kr

  • PRINCIPAL DISPLAY PANEL

    Vitamin E

    Vitalizing Sunscreen

    Tocopherol

    SPF 50+ sunscreen contains Vitamin E

    to protect your skin from light (UV rays)

    and heat (Aging signs) leaving your

    skin healthy and moisturized.

    SPF50+ BROAD SPECTRUM

    50mL /1.69 fl. oz.

    COSRXcosrx

  • INGREDIENTS AND APPEARANCE
    COSRX 
    vitamin e vitalizing sunscreen lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70319-220
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4.5 mg  in 50 mL
    AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.25 mg  in 50 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE2.25 mg  in 50 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE4.5 mg  in 50 mL
    Inactive Ingredients
    Ingredient NameStrength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4) 0.65 mg  in 50 mL
    TRISILOXANE (UNII: 9G1ZW13R0G) 0.6 mg  in 50 mL
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) 0.5 mg  in 50 mL
    TRIMETHYLSILOXYSILICATE (M/Q 1.0-1.2) (UNII: 78GX033D7I) 0.5 mg  in 50 mL
    PEG-100 STEARATE (UNII: YD01N1999R) 0.325 mg  in 50 mL
    CETYL ALCOHOL (UNII: 936JST6JCN) 0.25 mg  in 50 mL
    CETETH-18 (UNII: 9E0067TYQH) 0.0075 mg  in 50 mL
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA) 0.04 mg  in 50 mL
    DIPHENYLSILOXY PHENYL TRIMETHICONE (UNII: I445L28B12) 1 mg  in 50 mL
    DIMETHICONE (UNII: 92RU3N3Y1O) 0.9 mg  in 50 mL
    ECHINACEA PURPUREA FLOWERING TOP WATER (UNII: G72P70SL42) 22.26195 mg  in 50 mL
    ANHYDROUS DEXTROSE (UNII: 5SL0G7R0OK) 0.0008 mg  in 50 mL
    1,3-PROPANEDIOL BIS(4-AMINOBENZOATE) (UNII: 8860R9ORQR) 5 mg  in 50 mL
    VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3) 0.85 mg  in 50 mL
    1,2-HEXANEDIOL (UNII: TR046Y3K1G) 0.5 mg  in 50 mL
    DOCOSANOL (UNII: 9G1OE216XY) 0.35 mg  in 50 mL
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) 0.325 mg  in 50 mL
    C14-22 ALCOHOLS (UNII: B1K89384RJ) 0.318 mg  in 50 mL
    POLYISOBUTYLENE (45000 MW) (UNII: YR8AQ94O31) 0.108 mg  in 50 mL
    EDETATE DISODIUM (UNII: 7FLD91C86K) 0.025 mg  in 50 mL
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P) 0.024975 mg  in 50 mL
    POLYSORBATE 20 (UNII: 7T1F30V5YH) 0.018 mg  in 50 mL
    SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) 0.016 mg  in 50 mL
    COCOA (UNII: D9108TZ9KG) 0.0075 mg  in 50 mL
    LEVANT COTTON SEED (UNII: 550E4N439V) 0.00225 mg  in 50 mL
    .ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01) 0.000025 mg  in 50 mL
    POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT) 0.25 mg  in 50 mL
    C12-20 ALKYL GLUCOSIDE (UNII: K67N5Z1RUA) 0.1 mg  in 50 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70319-220-011 in 1 CARTON01/09/2023
    150 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/01/2022
    Labeler - COSRX inc. (689516893)
    Registrant - COSRX inc. (689516893)
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