SUPER SPARKLE SCREEN BROAD SPECTRUM 30 SUNKISSED PINK GLITTER STRAWBERRY SCENTED- octinoxate, octisalate, zinc oxide cream

Super Sparkle Screen Broad Spectrum 30 Sunkissed Pink Glitter Strawberry Scented by

Drug Labeling and Warnings

Super Sparkle Screen Broad Spectrum 30 Sunkissed Pink Glitter Strawberry Scented by is a Otc medication manufactured, distributed, or labeled by Glitter Tots, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

SUPER SPARKLE SCREEN BROAD SPECTRUM 30 SUNKISSED PINK GLITTER STRAWBERRY SCENTED 
octinoxate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70239-706
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70239-706-01	1 in 1 CARTON	02/07/2017
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	11/10/2015

Labeler - Glitter Tots, LLC (036244306)