Label: OS-01 BODY SPF 30- zinc oxide cream

  • NDC Code(s): 62742-4264-1, 62742-4264-2
  • Packager: Allure Labs
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated June 20, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active ingredients – Zinc Oxide 14 %

  • PURPOSE

    Purpose – Sunscreen

  • INDICATIONS & USAGE

    Uses –

    Helps prevent sunburn
    If used as directed with other sun protection measures (See direction), decreases the risk of skin cancer and early skin aging caused by the sun.

  • WARNINGS

    Warning – For external use only

  • DO NOT USE

    Do not use on damaged or broken skin

  • WHEN USING

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

  • STOP USE

    Stop use and ask 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

    Direction-

    Apply liberally 15 minutes before sun exposure.
    Reapply after 80 minutes of swimming or sweating.
    immediately after towel drying, 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 the risk, regularly use a sunscreen with a broad-spectrum value of 15 or higher and other sun protection measures including:
    Limit time in the sun. especially from 10 am to 2 pm
    Wear long-sleeved shirts, pants hats and sunglasses.

  • OTHER SAFETY INFORMATION

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

  • INACTIVE INGREDIENT

    Inactive Ingredients: Caprylic/Capric Triglyceride 40 - 65 Butyloctyl Salicylate, C13-15 Alkane, Stearalkonium Hectorite,Coconut Alkanes, Euphorbia Cerifera (Candelilla) Wax, Helianthus Annuus (Sunflower) Seed Wax, Propylene Carbonate, Quaternium-90 Bentonite, Butyrospermum Parkii Nut Extract, Decapeptide-52, Camellia Oleifera (Tea) Seed Oil, Caesalpinia Spinosa Fruit Pod Extract, Helianthus Annuus (Sunflower) Sprout Extract, Aloe Barbadensis Leaf Extract, Carthamus Tinctorius Seed Oil, Lactobacillus/Acerola Cherry Ferment, Coco-Caprylate/Caprate, Ceramide NP, Ceramide AP, Ceramide EOP, Ethylhexylglycerin, Caprylyl Glycol, Hexylene Glycol, Polyhydroxystearic acid, Polyglyceryl-3 Polyricinoleate, Isostearic acid, Lecithin, Phytosphingosine, Cholesterol, Sodium lauroyl lactylate , Carbomer, Xanthan gum, Water, Propylene Glycol ,Triethyl Citrate, Citric Acid, Sodium Benzoate, Phenoxyethanol.

  • PRINCIPAL DISPLAY PANEL

    Body SPF 30

  • INGREDIENTS AND APPEARANCE
    OS-01 BODY SPF 30 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62742-4264
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE14 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BIFIDOBACTERIUM ANIMALIS LACTIS (UNII: 5307V7XW8I)  
    CANDELILLA WAX (UNII: WL0328HX19)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    SHEANUT (UNII: 84H6HBP32L)  
    PHYTOSPHINGOSINE (UNII: GIN46U9Q2Q)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    CAESALPINIA SPINOSA FRUIT POD (UNII: EXY4496LWD)  
    SAFFLOWER OIL (UNII: 65UEH262IS)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    POLYGLYCERYL-3 PENTARICINOLEATE (UNII: 7Q0OK5DOT4)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    HELIANTHUS ANNUUS SEED WAX (UNII: 42DG15CHXV)  
    SODIUM LAUROYL LACTYLATE (UNII: 7243K85WFO)  
    HELIANTHUS ANNUUS SPROUT (UNII: 4P26HG1S5W)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
    STEARALKONIUM HECTORITE (UNII: OLX698AH5P)  
    QUATERNIUM-90 BENTONITE (UNII: 97K5YEF88C)  
    CAMELLIA OIL (UNII: T1PE06G0VE)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    MALPIGHIA EMARGINATA SEED (UNII: 1X7L93686M)  
    CERAMIDE NP (UNII: 4370DF050B)  
    CERAMIDE AP (UNII: F1X8L2B00J)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    CHOLESTEROL (UNII: 97C5T2UQ7J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
    C13-15 ALKANE (UNII: 114P5I43UJ)  
    COCONUT ALKANES (UNII: 1E5KJY107T)  
    COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLENE CARBONATE (UNII: 8D08K3S51E)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62742-4264-21 in 1 CARTON06/20/2024
    1NDC:62742-4264-1100 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02006/20/2024
    Labeler - Allure Labs (926831603)
    Registrant - Allure LAbs (926831603)
    Establishment
    NameAddressID/FEIBusiness Operations
    Allure Labs926831603manufacture(62742-4264)