Label: BRUSH ON BLOCK SUN SHINE SPF 30 PROTECTIVE LIP OIL NUDE TINT- titanium dioxide/zinc oxide oil

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 5, 2024

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  • Active ingredients

    titanium dioxide 4.5%

    zinc oxide 3.4%

  • 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

    For external use only.

    Do not use

    Do not use on damaged or broken skin.

    When using this product

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

    Stop use and ask a doctor

    Stop use and ask a doctor if rash occurs.

    Keep out of reach of children

    If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply liberally 15 minutes before sun exposure.
    • reapply at least every 2 hours
    • use a water resistant sunscreen if swimming or sweating
    • Children under 6 months of age: Ask a doctor.
    • Sunprotection 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 10am-2pm
    • wear long-sleeved shirts, pants, hats and sunglasses.
  • Other Information

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

  • Inactive Ingredients

    ALUMINA

    ARGANIA SPINOSA KERNEL OIL

    BISABOLOL

    BUTYLENE/ETHYLENE/STYRENE COPOLYMER

    BUTYLOCTYL SALICYLATE

    CAPRYLIC/CAPRIC TRIGLYCERIDE

    CAPRYLYL GLYCOL

    CITRUS RETICULATA (TANGERINE) PEEL OIL

    ETHYLENE/PROPYLENE/STYRENE COPOLYMER

    FLAVOR

    HELIANTHUS ANNUUS (SUNFLOWER) SEED OIL

    HYDROGENATED POLYISOBUTENE

    IRON OXIDES

    PENTAERYTHRITYL TETRA-DI-T-BUTYL HYDROXYHYDROCINNAMATE

    POLYHYDROXYSTEARIC ACID

    RICINUS COMMUNIS (CASTOR) SEED OIL

    STEARIC ACID

    TOCOPHERYL ACETATE

  • Purpose

    Sunscreen

  • label

    label

  • INGREDIENTS AND APPEARANCE
    BRUSH ON BLOCK SUN SHINE SPF 30 PROTECTIVE LIP OIL NUDE TINT 
    titanium dioxide/zinc oxide oil
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58274-016
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE3.4 g  in 100 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.5 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
    POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE) (UNII: 255PIF62MS)  
    CASTOR OIL (UNII: D5340Y2I9G)  
    MANDARIN OIL (UNII: NJO720F72R)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLHEXYL PALMITATE (UNII: 2865993309)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorTANGERINEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58274-016-016.8 mL in 1 TUBE; Type 0: Not a Combination Product03/05/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/05/2024
    Labeler - SPF Ventures LLC (055483891)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dermaceutical Laboratories Limited Liability078457159manufacture(58274-016)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dermaceutical Laboratories Limited Liability080375664manufacture(58274-016)
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