Label: BLISS MAD ABOUT SMOOTH SMOOTHING MINERAL PRIMER BROAD SPECTRUM SPF 15 SUNSCREEN- 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 July 23, 2015

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  • Drug Facts

  • Active Ingredients

    Titanium Dioxide 6.90%

    Purpose

    Sunscreen

  • Use

    Helps prevent sunburn

  • Warning

    For external use only.

    Do not use

    on damaged or broken skin

    When using this product

    keep out of eyes. Rinse with water to remove.

    Stop use and ask doctor

    if rash occurs.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply generously to face 15 minutes before sun exposure.
    • children under 6 months of age: ask a doctor.
    • Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures.

                      • limit time in the sun,especially from 10 a.m.-2 p.m.
                      • wear long-sleeved shirts, pants, hats and sunglasses
                      • reapply at least every 2 hours
                      • use a water resistant sunscreen if swimming or sweating; immediately after towel drying

  • Inactive Ingredients

    Cyclopentasiloxane, Isododecane, Glyceryl Behenate, Peg-10 Dimethicone, Polysilicone-11, Alumina, Water, Methicone, Lauryl Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Prunus Persica (Peach) Fruit Extract, Vitis Vinifera (Grape) Seed Extract, Oenothera Biennis (Evening Primrose) Root Extract, Jasminum Officinale (Jasmine) Extract, Amaranthus Caudatus Seed Extract, Ethylhexylglycerin, Phenoxyethanol.

  • Other Information

    protect the product in this container from excessive heat and direct sun

  • Product Label

    Carton

  • INGREDIENTS AND APPEARANCE
    BLISS MAD ABOUT SMOOTH SMOOTHING MINERAL PRIMER BROAD SPECTRUM SPF 15 SUNSCREEN 
    titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69302-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE69 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ISODODECANE (UNII: A8289P68Y2)  
    GLYCERYL BEHENATE (UNII: R8WTH25YS2)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    WATER (UNII: 059QF0KO0R)  
    PEACH (UNII: 3OKE88I3QG)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    OENOTHERA BIENNIS ROOT (UNII: SL194W0S0F)  
    JASMINUM OFFICINALE FLOWER (UNII: 0Q8K841432)  
    AMARANTHUS CAUDATUS SEED (UNII: FJ722PPQ9M)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69302-100-3030 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35207/23/2015
    Labeler - HatchBeauty Labs, LLC (079109913)
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