Label: SHEER TINT MOISTURIZER SPF 15 ASAP SKIN PRODUCTS- titanium dioxide, zinc oxide lotion

  • 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 February 8, 2013

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  • ACTIVE INGREDIENT

    Active Ingredients Purpose

    Titanium Dioxide 4% Sunscreen
    Zinc Oxide 1% Sunscreen

    Uses: Help protect against sunburn

    Keep out of reach of children

    Stop use and ask a doctor if rash or irritation develops and lasts. Keep out of eyes.

    For external use only.
    Rinse with water to remove.
    If swallowed, get medical help or contact a poison control center right away.

    Directions
    Apply to clean face. smooth onto face and neck until thoroughly absorbed. Use daily as a base under make up.
    Children under 6 months of age: ask a doctor.

    Inactive Ingredients: Water (Aqua), Caprylic/capric triglyceride, butylene glycol, Methyl Gluceth-20, Ethylhexyl methoxycinnamate, Titanium Dioxide, Cetearyl Alcohol, Propylene glycol, glyceryl stearate, PEG-100 stearate, triacontanyl PVP, dimethicone, zinc oxide, phenoxyethanol, methylparaben, ethylparaben, butylparaben, propylparaben, Isobutylparaben, silica, citrus reticulata (tangerine) peel oil, camellia sinensis (white tea) leaf extract, punica granatum (pomegranate) fruit extract, polysorbate 20, Iron oxides (CI 77491, CI77492, CI77499).

  • PRINCIPAL DISPLAY PANEL

    image of back labelimage of front label

    Sheer tint moisturizer SPF 15
    With antioxidants

    broad spectrum
    Sunscreen lotion
    UVA+UVB protection

    75 mL/2.54fl oz

  • INGREDIENTS AND APPEARANCE
    SHEER TINT MOISTURIZER SPF 15  ASAP SKIN PRODUCTS
    titanium dioxide, zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76261-250
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4 g  in 100 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
    OCTINOXATE (UNII: 4Y5P7MUD51)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    ZINC OXIDE (UNII: SOI2LOH54Z)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    ETHYLPARABEN (UNII: 14255EXE39)  
    BUTYLPARABEN (UNII: 3QPI1U3FV8)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    ISOBUTYLPARABEN (UNII: 0QQJ25X58G)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CITRUS RETICULATA FRUIT OIL (UNII: 25P9H3QU5E)  
    BANCHA TEA LEAF/TWIG (UNII: EWI42IEH1C)  
    POMEGRANATE (UNII: 56687D1Z4D)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76261-250-0175 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35206/02/2011
    Labeler - AUSTRALIAN SKIN PRODUCTS PTY LTD (752403019)
    Registrant - AUSTRALIAN SKIN PRODUCTS PTY LTD (752403019)
    Establishment
    NameAddressID/FEIBusiness Operations
    Natural Beauty Care Pty Ltd749369716manufacture(76261-250)
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