SPARKLE SCREEN BROAD SPECTRUM 30 GLITTERING GOLD KIWI-PEAR SCENTED- titanium dioxide, zinc oxide cream

Sparkle Screen Broad Spectrum 30 Glittering Gold Kiwi-Pear Scented by

Drug Labeling and Warnings

Sparkle Screen Broad Spectrum 30 Glittering Gold Kiwi-Pear Scented by is a Otc medication manufactured, distributed, or labeled by GlitterTots LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredients

Titanium Dioxide 6.00%

Zinc Oxide 6.00%

Purpose

Sunscreen

Use

Helps prevent sunburn.

Warnings

For external use only;

Do not use

on damaged or broken skin;

Stop use and ask a doctor if

rash occurs;

When using this product

keep 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; Use a water resistant sunscreen if swimming or sweating; Reapply at least every two hours; Children under 6 months: Ask a doctor. 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.

Other information

Protect this product from excessive heat and direct sun.

Inactive ingredients

Aqua (Water), Aloe Barbadensis Leaf Juice, Octyl Palmitate, Glycerin, Lecithin, Polysorbate 20, Cetearyl Olivate, Sorbitan Olivate, Glitter (Polyethylene Terephthalate, Polymethyl Methacrylate, Polyurethane-33, FD&C Yellow #5), Styrene/Acrylates Copolymer, Cocos Nucifera (Coconut) Oil, Helianthus Annuus (Sunflower) Seed Oil, Xanthan Gum, Phenoxyethanol, Ethylhexylglycerin, Glycine Soja (Soybean) Oil, Petrolatum, Simmondsia Chinensis (Jojoba) Leaf Extract, Butyrospermum Parkii (Shea) Butter, Sodium Benzoate, Potassium Sorbate, Parfum (Fragrance), Tocopheryl Acetate (Vitamin-E), Beeswax, Camellia Sinensis Leaf Extract, Citrullus Lanatus (Watermelon) Fruit Extract, Vitis
Vinifera (Grape) Seed Extract, Algae Extract, Allantoin, Niacin.

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.

Packing Labeling:

INGREDIENTS AND APPEARANCE

SPARKLE SCREEN BROAD SPECTRUM 30 GLITTERING GOLD KIWI-PEAR SCENTED 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70239-703
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	60 mg  in 1 g
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	60 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLOCTYL PALMITATE (UNII: 3414KL792Z)
GLYCERIN (UNII: PDC6A3C0OX)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
COCONUT OIL (UNII: Q9L0O73W7L)
SUNFLOWER OIL (UNII: 3W1JG795YI)
XANTHAN GUM (UNII: TTV12P4NEE)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SOYBEAN OIL (UNII: 241ATL177A)
PETROLATUM (UNII: 4T6H12BN9U)
SIMMONDSIA CHINENSIS LEAF (UNII: 67G221EK95)
SHEA BUTTER (UNII: K49155WL9Y)
SODIUM BENZOATE (UNII: OJ245FE5EU)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
YELLOW WAX (UNII: 2ZA36H0S2V)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
WATERMELON (UNII: 231473QB6R)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
ALLANTOIN (UNII: 344S277G0Z)
NIACIN (UNII: 2679MF687A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70239-703-01	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 - GlitterTots LLC (036244306)