Label: TANRI SUNSCREEN SPF15- zinc oxide and titanium dioxide lotion
TANRI SUNSCREEN SPF30- zinc oxide and titanium dioxide lotion

  • 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 April 27, 2021

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS:

    Zinc Oxide,
    Titanium Dioxide

  • PURPOSE

    Purpose: Sunscreen

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    Children under 6 months, ask a doctor.

  • Uses

    Helps prevent sunburn. If used as directed with other sun protection measures(see Directions), decreases the risk of skin cancer, early aging by the sun

  • WARNINGS

    WARNINGS
    • 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 a doctor if a rash occurs. Keep out of reach of children
    • If product is swallowed, get medical help or contact a Poison Control Center
    right away.

  • Directions

    SHAKE WELL before use!
    Apply Liberally 15 minutes before sun exposure
    Reapply: After 80 minutes of swimming or sweating. At least every 2 hours.
                Immediately after towel drying.
    Spending time in the sun increases your risk of skin cancer & early skin aging.
    To decrease this risk, regularly use a sunscreen with a broad spectrum SPF
    of 15 or higher and other sun protection measures including:
    • limit time in the sun, especially from 10a.m. - 2p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses
    Children under 6 months, ask a doctor.

  • INACTIVE INGREDIENTS:

    Deionized Water, Cetearyl Alcohol, Cera Alba (Beeswax), Steareth-20, Cocos Nucifera (Coconut) Oil, Olivia Europaea (Olive) Oil, Caprylic Capric Triglycerides, Glycerin, Panthenol (Vitamin B5), Tocopherol Acetate (Vitamin E), Aloe Vera Leaf Juice, Simmondsia Chinensis (Jojoba) Seed Oil, Citric Acid, Caprylyl Glycol & Ethylhexylglycerin Mineral Based, Broad Spectrum. Water/Sweat resistant (80 minutes).

  • PRINCIPAL DISPLAY PANEL

    Tanri SPF15 Mineral Sunscreen - 6oz/177ml

    NDC: 81848-001

    Tanri SPF15 Mineral Sunscreen

    Tanri SPF30 Mineral Sunscreen - 3oz/89ml

    NDC: 81848-002

    Tanri SPF30 Mineral Sunscreen

  • INGREDIENTS AND APPEARANCE
    TANRI SUNSCREEN SPF15 
    zinc oxide and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81848-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION5 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    caprylyl glycol (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81848-001-01177 mL in 1 BOTTLE; Type 0: Not a Combination Product04/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/29/2021
    TANRI SUNSCREEN SPF30 
    zinc oxide and titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81848-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION7 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SYNTHETIC BEESWAX (UNII: 08MNR5YE2R)  
    COCOS NUCIFERA WHOLE (UNII: 245J88W96L)  
    OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLES (UNII: XO45V955LT)  
    CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    JOJOBA OIL (UNII: 724GKU717M)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    caprylyl glycol (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81848-002-0189 mL in 1 TUBE; Type 0: Not a Combination Product04/29/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35204/29/2021
    Labeler - Valley Cash & Carry, Inc. (961816043)
    Establishment
    NameAddressID/FEIBusiness Operations
    Valley Cash & Carry, Inc.961816043manufacture(81848-001, 81848-002)
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