Label: HYDRA INTENSIVE BLEMISH BALM SPF30 PA- titanium dioxide octinoxate zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 October 1, 2009

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    Titanium Dioxide, Ethylhexyl Methoxycinnamate, Zinc Oxide, Rosmarinus Officinalis (Rosemary) Leaf Oil, Portulaca Oleracea Extract, Citrus Grandis (Grapefruit) Peel Extract, Camellia Sinensis Leaf Extract

  • KEEP OUT OF REACH OF CHILDREN

    CAUTION: Keep away from children.

  • WHEN USING

    DIRECTION OF USE:

    Apply thin layer of blemish balm onto all over the face.  Use fingertips to spread gently until it has been completely absorbed.

  • PRINCIPAL DISPLAY PANEL


    Label18c



    LABEL

  • INGREDIENTS AND APPEARANCE
    HYDRA INTENSIVE BLEMISH BALM SPF30 PA 
    titanium dioxide octinoxate zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43948-7001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM - UNII:D1JT611TNE) TITANIUM DIOXIDE3 mL  in 60 mL
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE1.8 mL  in 60 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC - UNII:J41CSQ7QDS) ZINC OXIDE0.3 mL  in 60 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43948-7001-160 mL in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35211/01/2009
    Labeler - The Doctor's Cosmetic Inc (687479378)
    Registrant - The Doctor's Cosmetic Inc (687479378)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Doctor's Cosmetic Inc687479378manufacture
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