Label: STATE-48 SUNCARE MINERAL SPF-30- zinc oxide, octisalate, octocrylene cream

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

Drug Label Information

Updated December 13, 2024

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

  • Drug Facts

  • Active Ingredients

    Zinc Oxide 6.00%

    Octisalate 5.00%,

    Octocrylene 5.00%

    Purpose

    Sunscreen

  • Uses

    • Helps prevent sunburn.
    • Higher SPF gives more sunburn protection
    • If used as directed with other sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun Directions
  • Warnings:

    For externel use only

    Do not use

    • on damaged or broken skin.

    When using this product

    • keep out of eyes. Rinse with water to remove. 

    Stop use and ask a doctor if

    rash or irritation develops and lasts.

    Keep out of reach of children.

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

  • Directions:

    • Apply liberally 15 minutes before sun exposure.
    • Children under 6 months of age:ask a doctor
    • Reapply at least every 2 hours.
    • Reapply as needed or after towel drying swimming or sweating.
    • Use a ater-resistant sunscreen if swimming or sweating.
    • 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:  Sun Protection Measures.
    • Limit time in the sun, especially from 10a.m. - 2.p.m. 
    • Wear long-sleeved shirts, pants, hats, and sunglasses.
  • Inactive Ingredients

    Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Argania Spinosa (Argan) Oil, Bixa Orellana (Annatto) Extract, Butylcotyl Salicylate, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Chamomilla Recutita (Chamomile) Extract, Daucus Carota Sativa (Carrot) Extract, Decyl Glucoside, Dodecane, Ethyl Vanillin, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, Glyceryl Undecylenate, Helianthus Annuus (Sunflower)Oil, Hydroxyethylcellulose, Leuconostoc/Radih Root Ferment Filtrate, Mangifera Indica (Mango) Butter, Persea Gratissima (Avocado) Oil, Polyhydroxystearic Acid, Stearic Acid, Xanthan Gum, Zemea (Corn) Propanediol.

  • Other Information

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

  • Questions?

    Call 877-266-8157

  • Package Labeling:

    Bottle

  • INGREDIENTS AND APPEARANCE
    STATE-48 SUNCARE MINERAL SPF-30 
    zinc oxide, octisalate, octocrylene cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81200-109
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION60 mg  in 1 mL
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 mL
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    BIXA ORELLANA SEED (UNII: O87354RZ5A)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CHAMOMILE (UNII: FGL3685T2X)  
    CARROT (UNII: L56Z1JK48B)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    DODECANE (UNII: 11A386X1QH)  
    ETHYL VANILLIN (UNII: YC9ST449YJ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL CAPRYLATE (UNII: TM2TZD4G4A)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    HYDROXYETHYL CELLULOSE, UNSPECIFIED (UNII: T4V6TWG28D)  
    LEUCONOSTOC/RADISH ROOT FERMENT FILTRATE (UNII: D2QHA03458)  
    MANGO (UNII: I629I3NR86)  
    AVOCADO OIL (UNII: 6VNO72PFC1)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CORN (UNII: 0N8672707O)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81200-109-00177 mL in 1 TUBE; Type 0: Not a Combination Product12/01/202008/01/2023
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02012/01/202008/01/2023
    Labeler - State 48 Suncare LLC (120989740)