Label: PREVENTION SUN SERUM SPF30- zinc oxide cream

  • NDC Code(s): 62742-4225-1, 62742-4225-2, 62742-4225-3
  • Packager: Allure Labs
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 9, 2024

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENT

    Active ingredient

    Zinc Oxide 15.6%

  • PURPOSE

    Purpose

    Sunscreen

  • INDICATIONS & USAGE

    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

    Warnings

    For external use only

  • DO NOT USE

    Do not use on damaged or broken skin

  • WHEN USING

    When using this product keep out of eyes. Rinse with water to remove

  • STOP USE

    Stop use and ask a doctor if rash occurs

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Shake well before use • apply generously 15 minutes before sun exposure • children under 6 months of age: Ask a doctor • reapply at least every 2 hours • use a water resistant sunscreen if swimming or sweating • 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

  • OTHER SAFETY INFORMATION

    Other information • protect the product in this container from excessive heat and direct sun

  • INACTIVE INGREDIENT

    Inactive ingredients:

    ISODODECANE, SQUALANE, POLYSILICONE-11, PROPANEDIOL DICAPRYLATE/CAPRATE, POLYGLYCERYL-3 POLYRICINOLEATE, POLYHYDROXYSTEARIC ACID, TRIETHOXYCAPRYLYLSILANE, LECITHIN, TOCOPHERYL ACETATE, CITRUS AURANTIUM DULCIS (ORANGE) PEEL OIL ZINGIBER OFFICINALE (GINGER) ROOT EXTRACT, LIMONENE, CAMELLIA OLEIFERA SEED OIL, TETRAHEXYLDECYL ASCORBATE, PRUNUS ARMENIACA (APRICOT) KERNEL OIL, CARTHAMUS TINCTORIUS (SAFFLOWER) SEED OIL, ALOE BARBADENSIS LEAF EXTRACT, CITRAL, LINALOOL, CITRIC ACID.

  • PRINCIPAL DISPLAY PANEL

    Prevention Sun Serum

  • INGREDIENTS AND APPEARANCE
    PREVENTION SUN SERUM SPF30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4225
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE15.6 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    ORANGE OIL (UNII: AKN3KSD11B)  
    GINGER (UNII: C5529G5JPQ)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)  
    CITRAL (UNII: T7EU0O9VPP)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    ISODODECANE (UNII: A8289P68Y2)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    PROPANEDIOL DICAPRYLATE/CAPRATE (UNII: F53961BX4F)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    SQUALANE (UNII: GW89575KF9)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    CAMELLIA OIL (UNII: T1PE06G0VE)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    APRICOT KERNEL OIL (UNII: 54JB35T06A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4225-17 g in 1 TUBE; Type 0: Not a Combination Product01/05/2023
    2NDC:62742-4225-31 in 1 CARTON01/05/2023
    2NDC:62742-4225-228.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02001/05/2023
    Labeler - Allure Labs (926831603)
    Registrant - Allure Labs (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs926831603manufacture(62742-4225)