SUPER SPARKLE SCREEN BROAD SPECTRUM 30 SUNKISSED GOLD GLITTER TANGERINE SCENTED- octinoxate, octisalate, zinc oxide cream
Glitter Tots, LLC

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Super Sparkle Screen Broad Spectrum 30+ Sunkissed Gold Glitter Tangerine Scented

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, FD&C Yellow #5, D&C Red #7; 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:

label3

SUPER SPARKLE SCREEN BROAD SPECTRUM 30 SUNKISSED GOLD GLITTER TANGERINE SCENTED
octinoxate, octisalate, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70239-705
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
SORBITAN OLIVATE (UNII: MDL271E3GR)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70239-705-01	1 in 1 CARTON	02/07/2017	05/16/2017
1		113 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	11/10/2015	05/16/2017

Labeler - Glitter Tots, LLC (036244306)

Revised: 10/2023

Document Id: 074bbf1c-73e5-db2d-e063-6394a90a3a11

Set id: 5f63dfa3-5952-4d47-abdf-ee7cc8e2eb46

Version: 4

Effective Time: 20231009

Glitter Tots, LLC