SUPER SPARKLE SCREEN BROAD SPECTRUM 30 SUNKISSED PINK GLITTER STRAWBERRY SCENTED (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GLITTER TOTS, LLC]

SUPER SPARKLE SCREEN BROAD SPECTRUM 30 SUNKISSED PINK GLITTER STRAWBERRY SCENTED (OCTINOXATE, OCTISALATE, ZINC OXIDE) CREAM [GLITTER TOTS, LLC]
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NDC 70239-706-01
Set ID ee7f3772-2a5c-4494-910e-44a3c896965f
Category HUMAN OTC DRUG LABEL
Packager Glitter Tots, LLC
Generic Name
Product Class
Product Number
Application Number PART352
  • Drug Facts

  • Active ingredients

    Octinoxate  7.50%

    Octisalate  3.00%

    Zinc Oxide  3.00%

    Purpose

    Sunscreen

  • Use

    Helps prevent sunburn.

  • Warnings

    For external use only

    Do not use

    on damaged or broken skin;

    Stop use and ask doctor

    if rash occurs;

    When using this product

    kepp out of eyes. Rinse with water to remove.

    Keep out of reach of children.

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

  • Directions

    •Apply liberally and evenly 15 minutes before sun exposure; Reapply: • After 80 minutes of swimming or sweating, •Immediately 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 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. •Children under 6 months: Ask a doctor.

  • Other information

    Protect this product from excessive heat and direct sunlight.

  • Inactive ingredients

    Water, Aloe Barbadensis Leaf Juice, Acrylates Copolymer, Polysorbate20, Helianthus Annuus (Sunflower) Seed Oil, PPG-17/IPDI/DMPA Copolymer, Zemea USP Propanediol, Glycerin, Caprylic/Capric Triglyceride, Cetyl Alcohol, Glyceryl Stearate SE, Glitte: Polyethylene Terephthalate, Polymethyl Methacrylate, Polyurethane-33, D&C Red #34; Cetearyl Olivate, Sorbitan Olivate, Camellia Sinensis Leaf Extract, Tocopheryl Acetate (Vitamin E), Ethylhexylglycerin, Phenoxyethanol Sodium Hydroxide, Parfum (Fragrance).

  • Questions or comments?

    Contact us directly at 1-888-600-1522
    Distr. by/par: GlitterTots LLC.
    1279 W Palmetto Park Rd, Boca Raton, FL 33486
    www.sparklescreen.com
    Patent Pending. All Rights Reserved.

  • Package Labeling:

    label4

  • INGREDIENTS AND APPEARANCE
    SUPER SPARKLE SCREEN BROAD SPECTRUM 30 SUNKISSED PINK GLITTER STRAWBERRY SCENTED 
    octinoxate, octisalate, zinc oxide cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70239-706
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE75 mg  in 1 g
    OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE30 mg  in 1 g
    ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION30 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    SUNFLOWER OIL (UNII: 3W1JG795YI)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CETYL ALCOHOL (UNII: 936JST6JCN)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    D&C RED NO. 34 (UNII: BAN556989E)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70239-706-011 in 1 CARTON02/07/2017
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35211/10/2015
    Labeler - Glitter Tots, LLC (036244306)

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