YOUTH 4 ACTIVATING BB CREAM SPF 30 DARK (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [SHAKLEE CORPORATION]

YOUTH 4 ACTIVATING BB CREAM SPF 30 DARK (ZINC OXIDE, TITANIUM DIOXIDE) LOTION [SHAKLEE CORPORATION]
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NDC 59899-013-01
Set ID 63f7f8bd-02f0-4a13-bb1e-298754b24fce
Category HUMAN OTC DRUG LABEL
Packager Shaklee Corporation
Generic Name
Product Class
Product Number
Application Number PART352
  • DRUG FACTS

  • ACTIVE INGREDIENT

    Zinc Oxide 6.30%

    Titanium Dioxide 2.36%

    PURPOSE

    Sunscreen

  • USES

    • Helps 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 occurs

    Keep out of reach of children.

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

  • DIRECTIONS

    • Apply generously 15 minutes before sun exposure
    • Children under 6 months of age: Ask a doctor
    • Sun Protection Measures. Spending time in the sun increases the risk of skin cancer and early skin aging caused by the sun. 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
    • Reapply at least every 2 hours 
    • Use a water-resistant sunscreen if swimming or sweating
  • OTHER INFORMATION

    • Protect the product in this container from excessive heat and direct sun
  • INACTIVE INGREDIENTS

    Water, Argania Spinosa (Argan) Kernel Oil, Tocopheryl Acetate (Vitamin E), Caprylic/Capric Triglyceride (Fractionated Coconut Oil), Silica,
    Orbignya Oleifera (Moringa Tree) Seed Oil, Vitis Rotundifolia (Muscadine Grape) Fruit Extract, Enteromorpha Compressa (Green Algae) Extract, Phenyl Trimethicone, Propanediol, Dimethicone, Butyloctyl Salicylate, Glycerin, Polyhydroxystearic Acid, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/ Sebacate, Polyglyceryl-2 Oleate, Trisiloxane, Magnesium Sulfate, Alteromonas Ferment Extract, Panthenol (Vitamin B5), Vitis Vinifera (Grape) Seed Extract, Magnesium Ascorbyl Phosphate (Vitamin C), Bisabolol, Caesalpinia Spinosa (Tara Tree) Gum, Phenoxyethanol, Butylene Glycol, Polyglyceryl-2 Stearate, Isostearic Acid, Sucrose Dilaurate, Lecithin, Polyglyceryl-3 Polyricinoleate, Disteardimonium Hectorite, Triethoxycaprylylsilane, Cetearyl Dimethicone Crosspolymer, Alumina, Sodium Cocoyl Glutamate, Stearic Acid, Ethylhexylglycerin, Trisodium Ethylenediamine Disuccinate, Dimethicone/Vinyl Dimethicone Crosspolymer, Superoxide Dismutase, 1,2-Hexanediol, Beta-Glucan, Caprylyl Glycol, Pisum Sativum (Pea) Extract May Contain Titanium Dioxide (C.I. 77891), Iron Oxides (C.I. 77491, 77492, 77499)

  • Package Labeling:

    Outer Package5Inner Package5

  • INGREDIENTS AND APPEARANCE
    YOUTH 4 ACTIVATING BB CREAM SPF 30 DARK 
    zinc oxide, titanium dioxide lotion
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59899-013
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION63 mg  in 1 mL
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE23.6 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ARGAN OIL (UNII: 4V59G5UW9X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BABASSU OIL (UNII: 8QSB4M5477)  
    MUSCADINE GRAPE (UNII: 072T3X480E)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PANTHENOL (UNII: WV9CM0O67Z)  
    VITIS VINIFERA SEED (UNII: C34U15ICXA)  
    MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)  
    SUCROSE DILAURATE (UNII: 5926LC4S7M)  
    DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L)  
    TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
    ALUMINUM OXIDE (UNII: LMI26O6933)  
    SODIUM COCOYL GLUTAMATE (UNII: BMT4RCZ3HG)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    SUPEROXIDE DISMUTASE (SACCHAROMYCES CEREVISIAE) (UNII: W2T4YRA9AD)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    PEA (UNII: W4X7H8GYFM)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59899-013-011 in 1 CARTON08/09/2017
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35208/09/2017
    Labeler - Shaklee Corporation (020284076)

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