Label: VERSED GUARDS UP DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF 35- zinc oxide 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 August 30, 2022

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  • Active Ingredient

    Zinc Oxide 15.2%

    Purpose

    Sunscreen

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

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Apply liberally and evenly 15 minutes before sun exposure
    • Reapply at least every 2 hours
    • Use a water resistant sunscreen if swimming or sweating, immediately after toweling drying, and at least every 2 hours
    • 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 othe sun protection measures including: limit time in sun, especially from 10 a.m. to 2 p.m. and wear long-sleeved shirts, pants, hats, and sunglasses
  • Other information

    Protect this product in this container from excessive heat and direct sun.

  • INACTIVE INGREDIENT

    Water/Aqua/Eau, Calcium Sodium Borosilicate, Butyloctyl Salicylate, Isodecyl Neopentanoate, Diheptyl Succinate, C18-21 Alkane, Erythritol, Cetearyl Alcohol, Sodium Stearoyl Glutamate, Capryloyl Glycerin/Sebacic Acid Copolymer, Propanediol, Arachidyl Alcohol, Glycerin, Pyrus Malus (Apple) Fruit Extract, Caprylic/Capric Triglyceride, Tocopherol, Caprylyl Glycol, Coco-Glucoside, Ethyl Ferulate, Behenyl Alcohol, Cetyl Alcohol, Arachidyl Glucoside, Bisabolol, Polyhydroxystearic Acid, Citric Acid, Sodium Gluconate, Xanthan Gum, Octyldodecyl Oleate, Caprylhydroxamic Acid, Hydrolyzed Jojoba Esters, Sodium Hyaluronate, Crithmum, Maritimum Extract, Maltodextrin, Moringa Oleifera Seed Extract, Aloe Barbadensis Leaf, Iron Oxides (CI 77491, CI 77492).

  • 75 mL Tube & Carton

    12

  • 50 mL Tube & Carton

    67

  • INGREDIENTS AND APPEARANCE
    VERSED GUARDS UP DAILY MINERAL SUNSCREEN BROAD SPECTRUM SPF 35 
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73690-027
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15.2 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    C18-C21 ALKANE (UNII: 33822S0M40)  
    ERYTHRITOL (UNII: RA96B954X6)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCO GLUCOSIDE (UNII: ICS790225B)  
    CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    DOCOSANOL (UNII: 9G1OE216XY)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    APPLE (UNII: B423VGH5S9)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CRITHMUM MARITIMUM WHOLE (UNII: J7IHY79BKY)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    ISODECYL NEOPENTANOATE (UNII: W60VYE24XC)  
    DIHEPTYL SUCCINATE (UNII: 057N7SS26Y)  
    CAPRYLOYL GLYCERIN/SEBACIC ACID COPOLYMER (2000 MPA.S) (UNII: N7YC58165T)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)  
    SODIUM GLUCONATE (UNII: R6Q3791S76)  
    OCTYLDODECYL OLEATE (UNII: MCA43PK7MH)  
    WATER (UNII: 059QF0KO0R)  
    ARACHIDYL ALCOHOL (UNII: 1QR1QRA9BU)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73690-027-0150 mL in 1 TUBE; Type 0: Not a Combination Product10/01/2021
    2NDC:73690-027-0275 mL in 1 TUBE; Type 0: Not a Combination Product04/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalM02010/01/2021
    Labeler - Offspring Beauty Co. (081516405)
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