Label: SUNSCREEN CREAM SPF 30- homosalate, octyl methoxycinnamate, benzophenone-3, titanium dioxide 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 January 24, 2019

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  • 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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