Label: REJUVENATING PRIMING MOISTURIZER BS SUNSCREEN SPF30- zinc oxide cream

  • NDC Code(s): 62742-4258-1, 62742-4258-2
  • Packager: Allure Labs
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 29, 2024

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  • ACTIVE INGREDIENT

    Active Ingredient:

    Zinc Oxide 16%

  • PURPOSE

    Purpose Sunscreen

  • INDICATIONS & USAGE

    Use(s) • 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 product is swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions • apply liberally and evenly to face 15 minutes before sun exposure • use a water-resistant sunscreen if swimming or sweating • reapply 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 10 a.m. - 2 p.m. • wear long-sleeve shirts, pants, hat and sunglasses • children under 6 months: Ask a doctor

  • OTHER SAFETY INFORMATION

    Other Information Protect this product from excessive heat & direct sun.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Brassica Napus Extract, Dimethicone, Cyclopentasiloxane, Caprylic/Capric Triglyceride, Glycerin, Propanediol, Bentonite, Cetearyl Alcohol, Polyglyceryl-8 Oleate, Sodium Chloride, Peptide-Rich Plasma® (sh-Oligopeptide-2, sh-Polypeptide-1, sh-Polypeptide-9, sh-Polypeptide-11, Acetyl Hexapeptide-8, sh-Oligopeptide-1, Palmitoyl Tripeptide-5, Palmitoyl Tetrapeptide-7, Acetyl Glutamine, Sodium Hyaluronate, Lysine HCL, Alanine, Histidine HCL, Arginine, Serine, Proline, Glutamic Acid, Threonine, Valine, Leucine, Glycine, Isoleucine, Phenylalanine, Taurine), Lactic Acid, Honey, Dimethylmethoxy Chromanyl Palmitate, Hydrolyzed Sodium Hyaluronate, Allantoin, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Bacillus/Folic Acid Ferment Filtrate Extract, Lecithin, Butylene Glycol, Maltodextrin, Mannitol, Xanthan Gum, Dimethicone/Vinyl Dimethicone Crosspolymer, Caprylyl Glycol, Citric Acid, Polysorbate 20, 1,2-Hexanediol, Polyhydroxystearic Acid, Phenoxyethanol, Ehtylhexylglycerin, Iron Oxides, Mica.

  • PRINCIPAL DISPLAY PANEL

    Rejuvenating Priming Moisturizer BS Sunscreen SPF30

  • INGREDIENTS AND APPEARANCE
    REJUVENATING PRIMING MOISTURIZER BS SUNSCREEN SPF30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4258
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE16 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLUTAMIC ACID (UNII: 3KX376GY7L)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    BRASSICA NAPUS WHOLE (UNII: NFP6814VZ4)  
    HISTIDINE MONOHYDROCHLORIDE (UNII: 1D5Q932XM6)  
    PROLINE (UNII: 9DLQ4CIU6V)  
    PHENYLALANINE (UNII: 47E5O17Y3R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    PALMITOYL TRIPEPTIDE-5 (UNII: 2A3916MQHO)  
    HYALURONATE SODIUM (UNII: YSE9PPT4TH)  
    ALLANTOIN (UNII: 344S277G0Z)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    BENTONITE (UNII: A3N5ZCN45C)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    MECASERMIN (UNII: 7GR9I2683O)  
    NEPIDERMIN (UNII: TZK30RF92W)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ALANINE (UNII: OF5P57N2ZX)  
    TAURINE (UNII: 1EQV5MLY3D)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    HONEY (UNII: Y9H1V576FH)  
    PALMITOYL TETRAPEPTIDE-7 (UNII: Q41S464P1R)  
    SERINE (UNII: 452VLY9402)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    MANNITOL (UNII: 3OWL53L36A)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    THREONINE (UNII: 2ZD004190S)  
    ISOLEUCINE (UNII: 04Y7590D77)  
    FOLIC ACID (UNII: 935E97BOY8)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    FIBROBLAST GROWTH FACTOR-1 (UNII: G53298VN9Y)  
    GLYCINE (UNII: TE7660XO1C)  
    CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    BASIC FIBROBLAST GROWTH FACTOR (HUMAN) (UNII: S3529G9M9V)  
    ACETYL HEXAPEPTIDE-8 (UNII: L4EL31FWIL)  
    ACEGLUTAMIDE (UNII: 01J18G9G97)  
    LEUCINE (UNII: GMW67QNF9C)  
    WATER (UNII: 059QF0KO0R)  
    HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    MICA (UNII: V8A1AW0880)  
    LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM)  
    ARGININE (UNII: 94ZLA3W45F)  
    VALINE (UNII: HG18B9YRS7)  
    DIMETHYLMETHOXY CHROMANYL PALMITATE (UNII: 5G222ZDK7U)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4258-21 in 1 CARTON03/29/2024
    1NDC:62742-4258-130 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/29/2024
    Labeler - Allure Labs (926831603)
    Registrant - Allure Labs (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs926831603manufacture(62742-4258)