Label: KOPHER CALMING OCEAN SUN- ethylhexyl methoxycinnamate, zinc oxide, ethylhexyl salicylate, titanium dioxide cream

  • NDC Code(s): 83069-010-01, 83069-010-02
  • Packager: Best Innovation
  • 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 October 27, 2022

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  • ACTIVE INGREDIENTS

    Ethylhexyl Methoxycinnamate 7.50%
    Zinc Oxide 4.00%
    Ethylhexyl Salicylate 3.00%
    Titanium Dioxide (CI 77891) 1.60%

  • INACTIVE INGREDIENTS

    Glacier Water, Cyclopentasiloxane, Butylene Glycol, Dicaprylyl Carbonate, Isoamyl p-Methoxycinnamate, Cyclohexasiloxane, Cetyl PEG/PPG-10/1 Dimethicone, Niacinamide, Diphenylsiloxy Phenyl Trimethicone, Alcohol Denat., Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Centella Asiatica Extract, Sodium Chloride, Asiaticoside, Madecassic Acid, Asiatic Acid, Spirulina Platensis Extract, Scutellaria Baicalensis Root Extract, Cinnamomum Zeylanicum Bark Extract, Camellia Japonica Seed Oil, Ceresin, Allantoin, Disteardimonium Hectorite, Sorbitan Sesquioleate, Silica, Sorbitan Olivate, Trihydroxystearin, Trimethylsiloxysilicate, Dipropylene Glycol, Propylene Carbonate, 1,2-Hexanediol, Hydroxyacetophenone, Phenyl Trimethicone, Triethoxycaprylylsilane, Dimethicone Crosspolymer, CI 77492, Dimethiconol, Adenosine, Dimethicone, CI 77491, Tocopherol, Menthyl Lactate, Butyl Methoxydibenzoylmethane, Butyl Avocadate, Tocopheryl Acetate, Horse Fat, Lauryl PEG-9 Polydimethylsiloxyethyl Dimethicone, Capryloyl Glycine, Hexylene Glycol, Sarcosine, Chlorphenesin, Water, Talc, Fragrance(Parfum)

  • PURPOSE

    Sunscreen

  • 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 use and ask a doctor if rash occurs.
    ■ Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control

  • Uses

    ■ Helps prevent sunburn
    ■ Higher SPF gives more sunburn protection
    ■ Retains SPF after 80 minutes of activity in the water or sweating

  • Directions

    ■ Apply liberally and uniformly to all exposed areas 15-20 minutes before sun exposure.
    ■ Reapply often (every 2 hours) and after swimming, excessive perspiration and washing to ensure maximum sun protection.

  • Other Information

    ■ Do not store this product in an inappropriate place such as high or low temperatures or under direct sun light

  • Questions

    ■ www.bestinnovation.co.kr

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of carton

  • INGREDIENTS AND APPEARANCE
    KOPHER CALMING OCEAN SUN 
    ethylhexyl methoxycinnamate, zinc oxide, ethylhexyl salicylate, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:83069-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.50 g  in 100 mL
    Zinc Oxide (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION4.0 g  in 100 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE3.0 g  in 100 mL
    Titanium Dioxide (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) Titanium Dioxide1.60 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:83069-010-021 in 1 CARTON10/01/2022
    1NDC:83069-010-0150 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 finalpart35210/01/2022
    Labeler - Best Innovation (695668556)
    Registrant - Best Innovation (695668556)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cit Co., Ltd.690081646manufacture(83069-010)
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