Label: SEA STAR SPARKLE SPF 50 GLITTER SUNSCREEN COTTON CANDY- homosalate, octocrylene, octisalate, zinc oxide cream

  • NDC Code(s): 72085-308-00
  • Packager: MJ Products Association, LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 5, 2023

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  • Drug Facts

  • Active Ingredients

    Homosalate 10.00%

    Octocrylene 5.00%

    Octisalate 5.00%

    Zinc Oxide 4.00%

    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.
    • 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 suncreen with broad spectrum protection and on SPF rating of 15 or higher, along with other sun protection measures including: Limit time in the sun, especially between 10am and 2pm.  SUN PROTECTION MEASURES:
    • Wear long sleeve shirts, pants, hats, and sunglasses.
    • For children under 6 months, consult a physician.

    REAPPLY:

  • Other Ingredients

    Acrylate Copolymer, Aloe Barbadensis Leaf (Aloe Vera Gel), Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Camellia Sinensis (Green Tea), Extract, Caprylic/Capric Triglyceride, Cetearyl Olivate, Cetyl Alcohol, Citric Acid, Ethylhexylglycerin, Glitter: Regenerated Cellulose/Rayon, FD&C Yellow #5, D&C Red 34, Aluminium; Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, Parfum (Fragrance), Phenoxyethanol, Polysorbate-20, Sorbitan Olivate, Styrene/Acrylates Copolymer, Tocopherol Acetate (Vitamin E), Zemea (Corn) Propanediol.

  • Other Information

    Protect this product from excessive heat and direct sunlight.

  • Questions or comments?

    Contact us directly at 1-888-601-0441

  • Package Labeling: 

    Label8

  • INGREDIENTS AND APPEARANCE
    SEA STAR SPARKLE SPF 50 GLITTER SUNSCREEN COTTON CANDY 
    homosalate, octocrylene, octisalate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72085-308
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 g
    OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE50 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE50 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    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)  
    REGENERATED CELLULOSE (UNII: BX81F82EWG)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 34 (UNII: BAN556989E)  
    ALUMINUM (UNII: CPD4NFA903)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CORN (UNII: 0N8672707O)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72085-308-00113 g in 1 PACKET; Type 0: Not a Combination Product08/10/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02008/10/2020
    Labeler - MJ Products Association, LLC (081022202)
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