SUNSCREEN CREAM SPF 30 (HOMOSALATE, OCTYL METHOXYCINNAMATE, BENZOPHENONE-3, TITANIUM DIOXIDE) CREAM [DAVEMED HEALTHCARE CO., LTD]

SUNSCREEN CREAM SPF 30 (HOMOSALATE, OCTYL METHOXYCINNAMATE, BENZOPHENONE-3, TITANIUM DIOXIDE) CREAM [DAVEMED HEALTHCARE CO., LTD]
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NDC 70897-008-01
Set ID 803bf1cc-331b-2ce7-e053-2a91aa0a1d53
Category HUMAN OTC DRUG LABEL
Packager Davemed Healthcare Co., Ltd
Generic Name
Product Class
Product Number
Application Number PART352
  • Active Ingredients

    Active ingredients Purpose

    Homosalate..................................Sunscreen

    Octyl methoxycinnamate..............Sunscreen

    Benzophenone-3..........................Sunscreen

    Titanium dioxide...........................Sunscreen

  • Purpose

    Active ingredients Purpose

    Homosalate..................................Sunscreen

    Octyl methoxycinnamate..............Sunscreen

    Benzophenone-3..........................Sunscreen

    Titanium dioxide...........................Sunscreen

  • Uses

    Uses

    • Helps prevent sunburn
    • Higher SPF gives more protection
    • For skin highly sensitive to sunburn
  • WARNINGS

    For external use only

    When using this product

    • Keep out eyes. Rinse with water to remove

    Stop use and ask a doctor if rash or irritation develops and lasts

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children

    • if swallowed, contact a poison control center or doctor right away
  • Directions

    • Apply liberally before sun exposure and as needed
    • Children under 6 months of age: ask a doctor
  • Inactive ingredients

    Water, Cetearyl Alcohol, Glycerin monosteareate Gctt, Propylparaben, Methylparaben, glycerol, EDTA-2NA, Vinylchloride-methylacrylate, copolymer, Methylisothiazolinone

  • Other Information

    Other Information

    Store at room temperature

  • Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    SUNSCREEN CREAM SPF 30 
    homosalate, octyl methoxycinnamate, benzophenone-3, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70897-008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE4 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4 g  in 100 mL
    OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    EDETIC ACID (UNII: 9G34HU7RV0)  
    VINYL CHLORIDE (UNII: WD06X94M2D)  
    GLATIRAMER ACETATE (UNII: 5M691HL4BO)  
    DIGLYCERIN MONOSTEARATE (UNII: E3XK1VOF1Y)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70897-008-016 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35202/01/2019
    Labeler - Davemed Healthcare Co., Ltd (529128716)
    Establishment
    NameAddressID/FEIBusiness Operations
    Davemed Healthcare Co., Ltd529128716manufacture(70897-008)

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