EVERYDAY UV PROTECTOR SUN SCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [DERMAL KOREA CO., LTD]

EVERYDAY UV PROTECTOR SUN SCREEN (HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE) CREAM [DERMAL KOREA CO., LTD]
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NDC 71882-010-01
Set ID 39c34e53-eff3-457e-a021-6d268439a1cd
Category HUMAN OTC DRUG LABEL
Packager Dermal Korea Co., Ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • ACTIVE INGREDIENT

    Active ingredients: Homosalate 7.00%, Ethylhexyl Salicylate 4.50%, Butyl Methoxydibenzoylmethane 3.00%, Octocrylene 1.00%

  • INACTIVE INGREDIENT

    Inactive ingredients: Water, Alcohol Denat., Dipropylene Glycol, Methyl Methacrylate Crosspolymer, Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine, Isoamyl p-Methoxycinnamate, Bis-PEG/PPG-20/5 PEG/PPG-20/5 Dimethicone, Methoxy PEG/PPG-25/4 Dimethicone, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Caprylic/Capric Triglyceride, Dimethicone, Caprylyl Glycol, Fragrance, Sodium Hydroxide, Ethylhexylglycerin, Centella Asiatica Extract, Adansonia Digitata Seed Extract, Aloe Barbadensis Leaf Extract, 1,2-Hexanediol, BHT, Disodium EDTA, Phenoxyethanol

  • PURPOSE

    Purpose: Sunscreen

  • WARNINGS

    Warnings: 1. Stop using if skin becomes red, swollen, itchy, etc during and after use. 2. Avoid using on irritated or sunburned skin by direct sunlight 3. Stop using on troubled skin part including eczema or dermatitis. 4. Avoid contact with the eyes. If contact occurs, rinse eyes thoroughly with water. 5. Keep away from the reach of baby and children. 6. Stored at room temperature only and keep away from direct sunlight.

  • DESCRIPTION

    Uses: In the last step of skin care, apply evenly to the areas which are exposed to ultraviolet such as face, neck, arm, leg and so on.

    Directions: It protects your skin from UVA/UVB and keeps your skin soft all day long without being sticky!

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Image of pouch

  • INGREDIENTS AND APPEARANCE
    EVERYDAY UV PROTECTOR SUN SCREEN 
    homosalate, octisalate, avobenzone, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71882-010
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) Homosalate1.05 g  in 15 g
    Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) Octisalate0.67 g  in 15 g
    Avobenzone (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) Avobenzone0.45 g  in 15 g
    Octocrylene (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) Octocrylene0.15 g  in 15 g
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Dipropylene Glycol (UNII: E107L85C40)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71882-010-0115 g in 1 POUCH; Type 0: Not a Combination Product10/01/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35210/01/2017
    Labeler - Dermal Korea Co., Ltd (688990247)
    Registrant - Dermal Korea Co., Ltd (688990247)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmecca Korea Co., Ltd.688830827manufacture(71882-010)

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