Label: SUMMER FRIDAYS SHADEDROPS BROAD SPECTRUM SPF 30 MINERAL MILK SUNSCREEN- zinc oxide cream

  • NDC Code(s): 81678-000-01, 81678-000-02
  • Packager: Summer Fridays LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 26, 2023

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

  • Drug Facts

  • Active Ingredients

    Zinc Oxide 9.40%

    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 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

    • Shake well • Apply liberally 15 minutes before sun exposure • Use a water resistant sunscreen if swimming or sweating • Reapply at least every 2 hours • Children under 6 months of age: Ask a doctor • 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 10 a.m. – 2 p.m. • Wear long-sleeved shirts, pants, hats, and sunglasses






    Sun Protection Measures.

  • Other Information

    Protect this product from excessive heat and direct sun

  • Inactive Ingredients

    Water, C12-15 Alkyl Benzoate, Sorbitan Oleate Decylglucoside Crosspolymer, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Ammonium Acryloyldimethyltaurate/VP Copolymer, Glycerin, Caramel, Polyester-5, Squalane, Butyrospermum Parkii (Shea) Butter Extract, Bisabolol, Phospholipids, Tocopherol, Ethyl Ferulate, Urea, Ethylhexylglycerin, Gluconolactone, Triethoxycaprylylsilane, Dimethicone, Sodium Chloride, Benzyl Alcohol, Sodium Benzoate, Sorbic Acid, Chlorphenesin, Phenoxyethanol.

  • Package Labeling:81678-000-01

    Outer PackageInner Package

  • Package Labeling:81678-000-02

    Outerpackage2

    InnerPackage2

  • INGREDIENTS AND APPEARANCE
    SUMMER FRIDAYS SHADEDROPS BROAD SPECTRUM SPF 30 MINERAL MILK SUNSCREEN 
    zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81678-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION94 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    POLYESTER-5 (TG-38) (UNII: 2L9351NW8W)  
    WATER (UNII: 059QF0KO0R)  
    ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARAMEL (UNII: T9D99G2B1R)  
    SQUALANE (UNII: GW89575KF9)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    TOCOPHEROL (UNII: R0ZB2556P8)  
    ETHYL FERULATE (UNII: 5B8915UELW)  
    UREA (UNII: 8W8T17847W)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCONOLACTONE (UNII: WQ29KQ9POT)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBIC ACID (UNII: X045WJ989B)  
    CHLORPHENESIN (UNII: I670DAL4SZ)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:81678-000-011 in 1 CARTON05/01/2022
    150 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:81678-000-021 in 1 CARTON05/01/2022
    25 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02005/01/2022
    Labeler - Summer Fridays LLC (118620216)