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NDC 70667-0745-01 bright guard SPF-30 SUNSCREEN 60; 60 mg/mL; mg/mL Details

bright guard SPF-30 SUNSCREEN 60; 60 mg/mL; mg/mL

bright guard SPF-30 SUNSCREEN is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Bright Guard, LLC. The primary component is TITANIUM DIOXIDE; ZINC OXIDE.

Product Information

NDC	70667-0745
Product ID	70667-745_48a74e28-1c41-61a5-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 SPF-30 SUNSCREEN
Proprietary Name Suffix	n/a
Non-Proprietary Name	TITANIUM DIOXIDE, ZINC OXIDE
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	60; 60
Active Ingredient Units	mg/mL; mg/mL
Substance Name	TITANIUM DIOXIDE; ZINC OXIDE
Labeler Name	Bright Guard, LLC
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2022-12-31

Package

Package Images

NDC 70667-0745-01 (70667074501)

Pricing Information	N/A
NDC Package Code	70667-745-01
Billing NDC	70667074501
Package	1000 mL in 1 BOTTLE (70667-745-01)
Marketing Start Date	2016-04-27
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 732b0681-226f-4684-9f6e-2702509c6db2 Details

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70667-745-01	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	04/27/2016

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

Labeler - Bright Guard, LLC (082779763)

Revised: 2/2017

Document Id: 48a74e28-1c41-61a5-e054-00144ff8d46c

Set id: 732b0681-226f-4684-9f6e-2702509c6db2

Version: 3

Effective Time: 20170216