SUNGLITTER PRINCESS- titanium dioxide, zinc oxide cream

Sunglitter Princess by

Drug Labeling and Warnings

Sunglitter Princess by is a Otc medication manufactured, distributed, or labeled by Products On The Go, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient:

Titanium dioxide 6%

Zinc Oxide 6%

Sun Protection

Uses:

• Helps prevent sunburn.
• If used as directed with other sun protection measures (see directions), decreases the risk of skin cancer and early skin aging caused by the sun.

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.

DIRECTION:

• Apply liberally 15-minutes before sun exposure.
• Reapply
• At least every two-hours.
• Immediately after swimming, sweating or towel drying.
• SUN PROTECTION MEASURES: Spending time in the sun increase your risk of skin cancer and early skin 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.
• For children under 6-months, consult a physician.

Other Ingredients:

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Camellia Sinensis (Green Tea) Extract, Cyanocobalamin (Vitamin B12), Daucus Carota Sativa (Carrot) Extract, Ethylhexylglycerin, Ethylhexyl Palmitate, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Extract, Lecithin, Parfum (Fragrance), Phenoxyethanol, Polyethylene Terephthalate (Glitter), Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sesamum Indicum (Sesame) Oil, Sodium Laurylglucosides Hydroxypropylsulfonate Theobroma Cacao (Cocoa) Butter, Tocopherol (Vitamin E), Xanthan Gum.

Package Labeling:

INGREDIENTS AND APPEARANCE

SUNGLITTER PRINCESS 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70668-826
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 CATION - UNII:13S1S8SF37)	ZINC CATION	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CYANOCOBALAMIN (UNII: P6YC3EG204)
CARROT (UNII: L56Z1JK48B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
SOYBEAN OIL (UNII: 241ATL177A)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALMOND OIL (UNII: 66YXD4DKO9)
SESAME OIL (UNII: QX10HYY4QV)
COCOA (UNII: D9108TZ9KG)
TOCOPHEROL (UNII: R0ZB2556P8)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70668-826-01	5 mL in 1 PACKET; Type 0: Not a Combination Product	05/10/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	05/10/2017

Labeler - Products On The Go, LLC (060619487)