Label: SEA STAR SPARKLE SPF-50 VERY BERRY- octinoxate, octisalate, octocrylene, zinc oxide cream

  • NDC Code(s): 72085-149-04
  • Packager: MJ Products Association, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 11, 2023

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  • Drug Facts

  • Active Ingredients

    Octinoxate 7.50%

    Octisalate 5.00%

    Octocrylene 5.00% 

    Zinc Oxide 5.00%

    Purpose

    Sunscreen

  • 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

    on damaged or broken skin.

    When using this product

    keep out of eyes. Rinse with water to remove.

    Stop use and consult physician

    if irritation or rash develops.

    Keep out of reach of children.

    If product is swallowed, get medical attention or contact poison control center immediately.

  • Directions

    • Apply liberally 15 minutes before sun exposure. REAPPLY:
    • At least every two-hours.
    • Immediately after swimming, sweating or towel drying. : Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:  SUN PROTECTION MEASURES
    • Limit time in the sun, especially between 10am to 2pm.
    • Wear long sleeve shirts, pants, hats and sunglasses.
    • For children under 6 months, consult a physician.
  • Other Ingredients

    Acrylates Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Ethylhexylglycerin, : Polyethylene Terephthalate, Polymethyl Methacrylate, Polyurethane-33, FD&C Yellow #5, D&C Red #7, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Parfum (Fragrance), Phenoxyethanol, Polysorbate-20, Sorbitan Olivate, Styrene/Acrylates Copolymer, Tocopherol Acetate (Vitamin E), Zemea (Corn) Propanediol. Glitter

  • Other information

    Protect this product from excessive heat and direct sunlight.

  • Questions or comments?

    Contact us directly at 1-888-601-0441

    Distr. by/par: Sunshine & Glitter

    MJ Products Association LLC

    9750 NW 17th Street, Miami, FL 33172

    www.sunshineglitter.com

    All Right Reserved.

  • Package Labeling

    VERY BERRY

  • INGREDIENTS AND APPEARANCE
    SEA STAR SPARKLE SPF-50 VERY BERRY 
    octinoxate, octisalate, octocrylene, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72085-149
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 7 (UNII: ECW0LZ41X8)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    STYRENE (UNII: 44LJ2U959V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72085-149-04113 g in 1 TUBE; Type 0: Not a Combination Product03/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02003/01/2018
    Labeler - MJ Products Association, LLC (081022202)
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