Label: ZINC FIVE-O SPF-50- zinc oxide lotion

  • Category: HUMAN OTC DRUG LABEL

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 January 27, 2022

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  • ACTIVE INGREDIENT

    ZINC OXIDE 25%

  • PURPOSE

    SUNSCREEN

  • USES

    • Helps prevent sunburn
    • If used as directed with other sun protection measures (see Directions), decreased 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 doctor if rash occurs.

  • DIRECTIONS:

    Apply liberally and evenly 15 minutes before sun exposure.

    Reapply: • After 40 minutes of swimming or sweating • Immediately after towel drying • At least every 2 hours 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 including:
    •Limit time in the sun, especially from 10 a.m. – 2 p.m.
    •Wear long-sleeved shirts, pants, hats, and sunglasses
    •Children under 6 months of age: ask a doctor.

  • OTHER INFORMATION

    Store at temperatures below 90°F.

  • INACTIVE INGREDIENTS

    Coco-caprylate/caprate, glycerine, coconut alkane, simmondsia chinensis (jojoba) seed oil, polyglyceryl-3-polyricinoleate, cera alba (beeswax), isostearic acid, polyhydroxy stearic acid, maltodextrin, phenylpropanol, propanediol, caprylyl glycol, tocopherol, ethylhexylglycerin, cetyl phosphate, sodium chloride, disodium EDTA

  • PRINCIPAL DISPLAY PANEL

    01b LBL_Zinc Five-0_Sunscreen_SPF-50_Page_101b LBL_Zinc Five-0_Sunscreen_SPF-50_Page_2

  • INGREDIENTS AND APPEARANCE
    ZINC FIVE-O  SPF-50
    zinc oxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80982-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION25 g  in 240 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    JOJOBA OIL (UNII: 724GKU717M)  
    POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)  
    YELLOW WAX (UNII: 2ZA36H0S2V)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    PHENYLPROPANOL (UNII: 0F897O3O4M)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CETYL PHOSPHATE (UNII: VT07D6X67O)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80982-003-39240 g in 1 TUBE; Type 0: Not a Combination Product11/20/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/20/2020
    Labeler - ASTIVITA LIMITED (742799513)
    Establishment
    NameAddressID/FEIBusiness Operations
    ASTIVITA LIMITED742799513label(80982-003)
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