YOUTH ACTIVATING BB SPF30 SHADE 3 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ENGLEWOOD LAB, INC.]

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  • YOUTH ACTIVATING BB SPF30 SHADE 3 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ENGLEWOOD LAB, INC.]

YOUTH ACTIVATING BB SPF30 SHADE 3 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [ENGLEWOOD LAB, INC.]
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NDC 14268-025-30
Set ID c84207c4-a779-4c00-a486-86eaf8ece169
Category HUMAN OTC DRUG LABEL
Packager Englewood Lab, Inc.
Generic Name
Product Class
Product Number
Application Number PART352
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  • DRUG FACTS

  • ACTIVE INGREDIENTS

    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 bu the sun. To decrease the 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 Simming or sweating
  • OTHER INFORMATION

    • Protect the product in this container from excessive heat and direct sun
  • SPL UNCLASSIFIED SECTION

  • 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 (CI 77891), Iron Oxides (CI 77491), 77492, 77499)

  • Package Labeling:

    Outer Package3Inner Package3

  • INGREDIENTS AND APPEARANCE
    YOUTH ACTIVATING BB SPF30 SHADE 3 
    zinc oxide, titanium dioxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:14268-025
    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 (UNII: H4N855PNZ1)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    BABASSU OIL (UNII: 8QSB4M5477)  
    MUSCADINE GRAPE (UNII: 072T3X480E)  
    PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TRISILOXANE (UNII: 9G1ZW13R0G)  
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)  
    PANTOTHENIC ACID (UNII: 19F5HK2737)  
    GRAPE (UNII: 6X543N684K)  
    ASCORBIC ACID (UNII: PQ6CK8PD0R)  
    LEVOMENOL (UNII: 24WE03BX2T)  
    CAESALPINIA SPINOSA RESIN (UNII: WL3883U2PO)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    POLYGLYCERYL-2 STEARATE (UNII: 253MC0P0YV)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    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)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:14268-025-301 in 1 CARTON11/22/2017
    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 finalpart35211/22/2017
    Labeler - Englewood Lab, Inc. (080987545)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab, Inc.080987545manufacture(14268-025)
    Establishment
    NameAddressID/FEIBusiness Operations
    Englewood Lab Korea Co., Ltd.690104005manufacture(14268-025)
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