Label: DOLLAR SHAVE CLUB DAILY FACE MOISTURIZER BROAD SPECTRUM SPF 25- octinoxate and zinc oxide cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated November 16, 2017

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Octinoxate 7.0%, Zinc Oxide 4.0%

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

    • 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: Ask a doctor

    Sun Protection 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 10 a.m.–2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
  • Other information

    • protect this product from excessive heat and direct sun.
  • Inactive ingredients

    Water/Aqua/Eau, Isocetyl Stearate, Sorbitol, Cetyl Dimethicone, Styrene/Acrylates Copolymer, Cetearyl Alcohol, Cyclopentasiloxane, Acrylates/Dimethicone Copolymer, Glyceryl Stearate, PEG-100 Stearate, Alcohol Denat., Ethylhexyl Salicylate, Ceteareth-20, Tocopheryl Acetate, VP/Eicosene Copolymer, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Ethylhexylglycerin, Polymethyl Methacrylate, Lecithin, Betula Alba (Birch) Bark Extract, Lepidium Sativum Sprout Extract, Salvia Officinalis (Sage) Leaf Extract, Cola Acuminata Seed Extract, Camellia Oleifera Leaf Extract, Vitis Vinifera (Grape) Fruit Cell Extract, Aloe Barbadensis Leaf Juice, Xanthan Gum, Isomalt, Disodium EDTA, Triethoxycaprylylsilane, Sodium Benzoate, Caprylyl Glycol, Phenoxyethanol, Fragrance (Parfum).

  • PRINCIPAL DISPLAY PANEL - 56.7 g Tube Label

    BIG CLOUD

    DAILY FACE
    MOISTURIZER
    with SPF

    "WISDOM WITHOUT AGE"

    FULL SHIELD
    SPF
    25
    UVA
    UVB
    BROAD SPECTRUM SPF 25

    PRESERVE YOUR NATURAL, YOUTHFUL
    LOOKS. APPLY THIS FEATHERWEIGHT
    MOISTURIZER WITH BROAD SPECTRUM
    SUN PROTECTION EVERY DAY.

    NET WT. 56.7 g • 2 OZ

    Principal Display Panel - 56.7 g Tube Label
  • INGREDIENTS AND APPEARANCE
    DOLLAR SHAVE CLUB DAILY FACE MOISTURIZER BROAD SPECTRUM SPF 25 
    octinoxate and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69522-2612
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE70 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION40 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOCETYL STEARATE (UNII: 3RJ7186O9W)  
    SORBITOL (UNII: 506T60A25R)  
    Cetostearyl Alcohol (UNII: 2DMT128M1S)  
    Cyclomethicone 5 (UNII: 0THT5PCI0R)  
    Glyceryl Monostearate (UNII: 230OU9XXE4)  
    PEG-100 Stearate (UNII: YD01N1999R)  
    Alcohol (UNII: 3K9958V90M)  
    Octisalate (UNII: 4X49Y0596W)  
    Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
    .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
    Vinylpyrrolidone/Eicosene Copolymer (UNII: 035MV9S1C3)  
    Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Betula Pubescens Bark (UNII: 3R504894L9)  
    Garden Cress Sprout (UNII: PWQ18YNR62)  
    Sage (UNII: 065C5D077J)  
    Cola Acuminata Seed (UNII: 1F8VIW1479)  
    Camellia Oleifera Leaf (UNII: 5077EL0C60)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Isomalt (UNII: S870P55O2W)  
    Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
    Triethoxycaprylylsilane (UNII: LDC331P08E)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69522-2612-456.7 g in 1 TUBE; Type 0: Not a Combination Product01/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35201/01/2016
    Labeler - DOLLAR SHAVE CLUB, INC. (004164494)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cosmetic Solutions LLC807907928manufacture(69522-2612)
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