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NDC 70667-0784-10 Bright Guard Water-Resistant SPF-30 Sunscreen 30; 100; 70; 50 mg/mL; mg/mL; mg/mL; mg/mL Details

Bright Guard Water-Resistant SPF-30 Sunscreen 30; 100; 70; 50 mg/mL; mg/mL; mg/mL; mg/mL

Bright Guard Water-Resistant SPF-30 Sunscreen is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Bright Guard, LLC. The primary component is AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE.

Product Information

NDC	70667-0784
Product ID	70667-784_477b067c-e4be-4110-e054-00144ff8d46c
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Bright Guard Water-Resistant SPF-30 Sunscreen
Proprietary Name Suffix	n/a
Non-Proprietary Name	HOMOSALATE,OCTINOXATE,OCTISALATE,AVOBENZONE
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	30; 100; 70; 50
Active Ingredient Units	mg/mL; mg/mL; mg/mL; mg/mL
Substance Name	AVOBENZONE; HOMOSALATE; OCTINOXATE; OCTISALATE
Labeler Name	Bright Guard, LLC
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2022-12-31

Package

Package Images

NDC 70667-0784-10 (70667078410)

Pricing Information	N/A
NDC Package Code	70667-784-10
Billing NDC	70667078410
Package	1000 mL in 1 BOTTLE (70667-784-10)
Marketing Start Date	2017-01-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 477b067c-e4bb-4110-e054-00144ff8d46c Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

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

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

Labeler - Bright Guard, LLC (082779763)

Revised: 2/2017

Document Id: 477b067c-e4be-4110-e054-00144ff8d46c

Set id: 477b067c-e4bb-4110-e054-00144ff8d46c

Version: 1

Effective Time: 20170201