Label: 6000X ELEMENTAL SCREEN BS SPF 30 SUNSCREEN- zinc oxide cream

  • NDC Code(s): 62742-4241-1, 62742-4241-2
  • Packager: Allure Labs
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 12, 2023

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

  • ACTIVE INGREDIENT

    Active Ingredients:

    Zinc Oxide 18.9%

  • PURPOSE

    Purpose: Sunscreen

  • INDICATIONS & USAGE

    Uses • helps to 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 • rash occurs.

  • KEEP OUT OF REACH OF CHILDREN

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

  • DOSAGE & ADMINISTRATION

    Directions • Apply liberally 15 minutes before sun exposure • Use a water-resistant sunscreen if swimming or sweating • Children under 6 months: Ask a doctor • Reapply: • after 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 of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10am - 2pm • wear long-sleeve shirts, pants, hats, and sunglasses.

  • OTHER SAFETY INFORMATION

    Other information • Protect this product from excessive heat or direct sun.

  • INACTIVE INGREDIENT

    Inactive Ingredients:

    Caprylic/Capric Triglyceride, Water (Aqua), Glycerin, Polysorbate 60*, Sorbitan Stearate, Stearic Acid, Cetearyl Glucoside, Cetyl Alcohol, Astaxanthin, Niacinamide (Vitamin B3), Ferulic Acid, Tocopherol (Vitamin E), Totarol (Podocarpus Totara), Mel (Manuka Honey), Phormium Tenax (Harakeke) Seed Oil, Gardenia Jasminoides Meristem Cell Culture, Punica Granatum (Pomegranate) Extract, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Aloe Barbadensis Leaf Juice, Carrageenan, Lecithin, Xanthan Gum, Sodium Phytate, Isostearic Acid, Polyhydroxystearic Acid, Polyglyceryl-3 Polyricinoleate, Dehydroacetic Acid, Stearyl Alcohol, Benzyl Alcohol. *Tween 60-LQ(AP)

  • PRINCIPAL DISPLAY PANEL

    6000X elemental Screen BS SPF 30 Sunscreen

  • INGREDIENTS AND APPEARANCE
    6000X ELEMENTAL SCREEN BS SPF 30 SUNSCREEN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4241
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE18.9 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    GARDENIA JASMINOIDES FRUIT (UNII: 7CTH8MD549)  
    ALMOND OIL (UNII: 66YXD4DKO9)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    PHYTATE SODIUM (UNII: 88496G1ERL)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    NIACINAMIDE (UNII: 25X51I8RD4)  
    TOTAROL (UNII: 67NH2854WW)  
    PHORMIUM TENAX SEED OIL (UNII: OZ80CEA779)  
    CARRAGEENAN (UNII: 5C69YCD2YJ)  
    CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    WATER (UNII: 059QF0KO0R)  
    FERULIC ACID (UNII: AVM951ZWST)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    HONEY (UNII: Y9H1V576FH)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ASTAXANTHIN (UNII: 8XPW32PR7I)  
    STEARYL ALCOHOL (UNII: 2KR89I4H1Y)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    DEHYDROACETIC ACID (UNII: 2KAG279R6R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4241-21 in 1 CARTON12/12/2023
    1NDC:62742-4241-159 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/12/2023
    Labeler - Allure Labs (926831603)
    Registrant - Allure Labs (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs926831603manufacture(62742-4241)