DAILY FACE MOISTURIZER (OCTINOXATE AND ZINC OXIDE) CREAM [COSMETIC SOLUTIONS LLC]

DAILY FACE MOISTURIZER (OCTINOXATE AND ZINC OXIDE) CREAM [COSMETIC SOLUTIONS LLC]
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NDC 66163-2612-8
Set ID 2c3b0d1d-f2f6-4b66-9586-1d2607e69962
Category HUMAN OTC DRUG LABEL
Packager Cosmetic Solutions LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • SPL UNCLASSIFIED SECTION

    DRUG FACTS:

  • ACTIVE INGREDIENTS

    Octinoxate 7.5%

    Zinc Oxide 4.8%

  • PURPOSE

    Sunscreen

  • USES

    Help prevent sunburn.

  • 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 or irritation occurs.

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • DIRECTIONS

    Apply liberally and evenly 15 minutes before sun exposure. 1Reapply:

    At least 80 minutes after swimming or sweating, immediately after towel drying, at least every 2 hours.

    • 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 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-sleeve shirts, pants, hats, and sunglasses.

    1
    For children under 6 months of age: Ask a doctor.
  • INACTIVE INGREDIENTS

    Water, Hydrogenated Polybutene, Octyl Stearate, Polyglyceryl-4-Isostearate, Aloe Barbadensis Leaf Extract, Isopropyl Palmitate, Cyclomethicone, Sunflower Oil, Hydrogenated Microcrystalline Wax, Cetyl Dimethicone Copolyol, Cetyl Dimethicone, Hydrogenated Castor Oil, Sodium Chloride, Polyglyceryl-3-Oleate, Silica, Hexyl Laurate, Triethoxycaprylylsilane, Capryly Glycol, Methylisothiazolinone.

  • OTHER INFORMATION

    Store at controlled temperature 15C – 30C (59F-86F). Protect the product in this container from excessive heat and direct sun.

  • SPL UNCLASSIFIED SECTION

    Manufactured By: Cosmetic Solutions LLC
    Boca Raton, FL 33487.

  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Label

    Professional
    Solutions
    PURE SCIENCE. BETTER SKIN

    sunscreen
    broad spectrum
    SPF 55

    moisturizing lotion

    e 60mL (2 Fl. Oz.)

    Principal Display Panel - 60 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    DAILY FACE MOISTURIZER 
    octinoxate and zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66163-2612
    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 Oxide - UNII:SOI2LOH54Z) Zinc Oxide40 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:66163-2612-860 g in 1 BOTTLE, PLASTIC; 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 - Cosmetic Solutions LLC (807907928)

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