BRIGHT GUARD SPF-30 SUNSCREEN- titanium dioxide, zinc oxide cream

bright guard SPF-30 SUNSCREEN by

Drug Labeling and Warnings

bright guard SPF-30 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by Bright Guard, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DRUG FACTS: 1000ml Volume

Active Ingredients

Titanium Dioxide               6.00%

Zinc Oxide                         6.00%

Purpose

Sunscreen

USES:

*Helps prevent sunburn.

*If used as directed with other sun protection measure (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.

DIRECTIONS:

*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 increases 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, Daucus Carota Sativa (Carrot) Extract,
Ethylhexylglycerin, Ethylhexyl Palmitate, Glycerin, Glycine Soja (Soybean) Oil, Helianthus Annuus (Sunflower) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Lauryglucosides Hydroxypropylsulfonate, Theobroma Cacao (Cocoa) Butter, Tocopherol (Vitamin E), Xanthan Gum

Other Information:

*Protect this product from excessive heat and direct sunlight.

COMMENTS OR QUESTIONS?

Visit www.BrightGuard.com or call (310)963-6896 Distributed by Bright Guard Corporation Newport Beach, Ca 92660

Package Labeling:

INGREDIENTS AND APPEARANCE

BRIGHT GUARD SPF-30 SUNSCREEN 
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70667-745
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)
CARROT (UNII: L56Z1JK48B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
GLYCERIN (UNII: PDC6A3C0OX)
SOYBEAN OIL (UNII: 241ATL177A)
HELIANTHUS ANNUUS FLOWERING TOP (UNII: BKJ0J3D1BP)
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: 70667-745-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	04/27/2016

Labeler - Bright Guard, LLC (082779763)