JUNGLE SCREEN SPF 30- titanium dioxide, zinc oxide lotion

Jungle Screen SPF 30 by

Drug Labeling and Warnings

Jungle Screen SPF 30 by is a Otc medication manufactured, distributed, or labeled by Pure Source, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Jungle Screen SPF 30

Active Ingredients

Titanium Dioxide  6.00%
Zinc Oxide  6.00%

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 consult physician

if irritation or rash develops.

Keep out of reach of children.

If product is swallowed, get medical attention or contact poison control center immediately.

DIRECTIONS:

Apply liberally 15 minutes before sun exposure.   Reapply: At least every two hours. Immediately after swimming, sweating or towel drying. For children under 6 months, consult a physician.

SUN PROTECTION MEASURES:

Spending time in the sun increases your risk of skin cancer and early sun aging. To decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including: Limit time in the sun, especially between 10am and 2pm. Wear long sleeve shirts, pants, hats and sunglasses.

OTHER INGREDIENTS:

Algae Extract, Allantoin, Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Beeswax, Butyrospermum Parkii (Shea) Butter, Camellia Sinensis (Green Tea) Leaf Extract, Cetearyl Olivate, Citrulllus Lanatus (Watermelon) Fruit Extract, Cocos Nucifera (Coconut) Oil, Glitter (Polyethylene Tetraphthalate, Polymethyl Methacrylate, Polyurethane-33, FD and C Yellow # 5, D and C Red #7), Cymbopogon Flexuosus (Lemongrass) Oil, Cymbopogon Nardus (Citronella) Oil, Ethyl Vanillin, Gluconolactone, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Seed Oil, Lecithin, Mentha Piperita (Peppermint) Oil, Niacin, Octyl Palmitate, Petrolatum, Polysorbate-20, Simmondsia Chinensis (Jojoba) Leaf Oil, Sodium Benzoate, Sorbitan Olivate, Thuja Occidentalis (Cedar) Leaf Oil, Tocopheryl Acetate (Vitamin-E), Vitis Vinifera (Grape) Seed Extract, Xanthan Gum.

QUESTIONS OR COMMENTS?

Contact us directly at www.glittertots.com GlitterTots LLC. Fort Lauderdale, FL 33348.

Jungle Screen SPF 30 3oz/90ml (

65121-494-03)

INGREDIENTS AND APPEARANCE

JUNGLE SCREEN SPF 30 
titanium dioxide, zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65121-494
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 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
YELLOW WAX (UNII: 2ZA36H0S2V)
SHEA BUTTER (UNII: K49155WL9Y)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
WATERMELON (UNII: 231473QB6R)
COCONUT OIL (UNII: Q9L0O73W7L)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
WEST INDIAN LEMONGRASS OIL (UNII: 5BIA40E9ED)
CITRONELLA OIL (UNII: QYO8Q067D0)
ETHYL VANILLIN (UNII: YC9ST449YJ)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
GLYCERIN (UNII: PDC6A3C0OX)
SOYBEAN OIL (UNII: 241ATL177A)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PEPPERMINT OIL (UNII: AV092KU4JH)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PETROLATUM (UNII: 4T6H12BN9U)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
SIMMONDSIA CHINENSIS LEAF (UNII: 67G221EK95)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SORBITAN OLIVATE (UNII: MDL271E3GR)
CEDAR LEAF OIL (UNII: BJ169U4NLG)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
VITIS VINIFERA SEED (UNII: C34U15ICXA)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65121-494-03	1 in 1 CARTON	02/10/2017
1		90 mL in 1 BOTTLE; 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	04/21/2014

Labeler - Pure Source, LLC (080354456)

Establishment
Name	Address	ID/FEI	Business Operations
Pure Source, LLC		080354456	manufacture(65121-494)