Label: TINTED MOISTURIZER SPF 20- zinc oxide titanium dioxide 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 August 31, 2011

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  • ACTIVE INGREDIENT

    Active ingredients:

    Zinc Oxide 7.5%

    Titanium Dioxide 4.4%

  • PURPOSE

    Purpose: Sunscreen
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.
  • INDICATIONS & USAGE

    This cream is enriched with moisturizing acai oil to help skin remain hydrated while adding a touch of color and glow to your skin.

    Uses

    ■ Helps prevent sunburn.

    ■ Higher SPF gives more sunburn protection.

    ■ Provides moderate protection against sunburn.

  • WARNINGS

    Warnings

    ■ For external use only.

    ■ When using this product, keep out of eyes. If contact occurs, rinse abundantly with water to remove.

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

    ■ If swallowed, seek medical assistance or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Directions

    ■ Apply in the morning and prior to sun exposure. Reapply as needed.

    ■ Children under 6 months of ask: ask a doctor.

  • INACTIVE INGREDIENT

    Inactive ingredients: Aqua/Water/Eau, Caprylic/Capric Triglyceride, Oleyl Oleate, Polyglyceryl-2 Dipolyhydroxystearate, Pentaerythrityl Tetraisostearate, Butylene Glycol, Cyclopentasiloxane, PEG/PPG-20/15 Dimethicone, Triethoxycaprylylsilane, Sodium Lauryl Glucose Carboxylate, Lauryl Glucoside, Glycerin, Xanthan gum, Magnesium Aluminum Silicate, Acai Fruit Oil, Citric Acid, Isononyl Isononanoate, Isopropyl Titanium Triisostearate, Synthetic Wax, Caprylyl Glycol, Phenoxyethanol, Sorbic Acid, Iron oxides (CI 77491, 77492).
  • PRINCIPAL DISPLAY PANEL

    B. KAMINS

    TINTED MOISTURIZER SPF15

    50mL / 1.7 fl.oz

    NPN 80026968

    image/jpg

    Tinted Moisturizer front panel image

  • INGREDIENTS AND APPEARANCE
    TINTED MOISTURIZER SPF 20 
    zinc oxide titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63550-158
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE75 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE44 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    DIBUTYL ADIPATE (UNII: F4K100DXP3)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    ACAI OIL (UNII: Z0W6766A2W)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
    WHITE WAX (UNII: 7G1J5DA97F)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SORBIC ACID (UNII: X045WJ989B)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63550-158-0350 mL in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35208/31/2011
    Labeler - Kamins Dermatologics Inc. (254050784)
    Registrant - Kamins Dermatologics Inc. (254050784)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kamins Dermatologics Inc.254050784manufacture, pack, label
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