BRIGHT GUARD WATER-RESISTANT SPF-30 SUNSCREEN- homosalate,octinoxate,octisalate,avobenzone lotion

Bright Guard Water-Resistant SPF-30 Sunscreen by

Drug Labeling and Warnings

Bright Guard Water-Resistant 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

Homosalate  10.00%

Octinoxate  7.00%

Octisalate  5.00%

Avobenzone  3.00%

Purpose

Sunscreen

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.

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 10 am and 2 pm.
       - Wear long sleeve shirts, pants, hats and sunglasses.
       - For children under 6-months, consult a physician.

OTHER INGREDIENTS:

Aloe Barbadensis (Aloe Vera Gel) Juice, Aqua (Deionized Water), Cetyl Alcohol, Citric Acid, Coco Nucifera (Coconut) Oil, Ethylhexylglycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Oil, PEG-100 Stearate, Phenoxyethanol, Polysorbate 80, Styrene/Acrylates Copolymer Tocopheryl Actetate (Vitamin E), Zemea (Corn) Propanediol.

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 WATER-RESISTANT SPF-30 SUNSCREEN 
homosalate,octinoxate,octisalate,avobenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70667-784
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	70 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
CETYL ALCOHOL (UNII: 936JST6JCN)
COCONUT OIL (UNII: Q9L0O73W7L)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SUNFLOWER OIL (UNII: 3W1JG795YI)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70667-784-10	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/02/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/02/2017

Labeler - Bright Guard, LLC (082779763)