Label: VERTRA PREMIUM SUNCARE SPF 30- titanium dioxide, zinc oxide spray

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 5, 2023

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  • Drug Facts

  • Active ingredient

    Titanium Dioxide 5.0% Zinc Oxide 5.0%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn

    • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

  • Warnings

    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 a doctor

    if rash occurs

    Keep out of reach of children

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

  • Directions

    • Apply liberally 15 minutes before sun exposure 

    • Reapply:

    • After 80 minutes of swimming or sweating

    • Immediately after towel drying

    • At least every 2 hours 

    • 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 15 or higher and other sun protection measures including: Sun Protection Measures.

    • 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

    Aqua (Deonized Water), Aloe Barbadensis Leaf Juice (Aloe Vera Gel), Ethylhexyl Palmitate, Zemea (Corn) Propanediol, Caprylic/Capric Triglyceride, Tridecyl Salicaylate, Decyl Glucoside, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Cocos Nucifera (Coconut) Oil,  Polyhydroxystearic Acid, Capryloyl Glycerin/Sebacic Acid Copolymer, Glycerin, Stearic Acid, Glyceryl Caprylate, Glyceryl Undecylenate,  Cetearyl Alcohol, Daucus Carota Sativa (Carrot) Extract, Camellia Sinensis (Green Tea) Extract, Citrullus Lanatus (Watermelon) Extract, Fucus Vesiculosus (Seaweed) Extract, Algae Extract, Tocopheryl Acetate (Vitamin E), Mangifera Indica (Mango) Butter, Hippophae Rhamnoides (Sea Buckthorn) Oil, Hydroxyethylcellulose, Xanthum Gum.

  • Other Information

    Protect this product from excessive heat and direct sunlight

  • Questions or comments?

    www.vertra.com

  • Package Labeling:

    LabelLabel2

  • INGREDIENTS AND APPEARANCE
    VERTRA PREMIUM SUNCARE SPF 30 
    titanium dioxide, zinc oxide spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71014-029
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE40 mg  in 1 mL
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION40 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    CORN (UNII: 0N8672707O)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    TRIDECYL SALICYLATE (UNII: AZQ08K38Z1)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    COCONUT OIL (UNII: Q9L0O73W7L)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL 1-UNDECYLENATE (UNII: B68LJT9544)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CARROT (UNII: L56Z1JK48B)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    WATERMELON (UNII: 231473QB6R)  
    NORI (UNII: 477TV3P5UX)  
    MANGO (UNII: I629I3NR86)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71014-029-00177 mL in 1 CAN; Type 0: Not a Combination Product02/21/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02002/21/2019
    Labeler - Eai-Jr286, Inc. (827896718)