BRIGHT GUARD NATURAL SPF 30- zinc oxide lotion

Bright Guard Natural SPF 30 by

Drug Labeling and Warnings

Bright Guard Natural SPF 30 by is a Otc medication manufactured, distributed, or labeled by Renu Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Bright Guard Natural SPF 30

ACTIVE INGREDIENT

Active Ingredients

Zinc Oxide 22%

Purpose

Sunscreen

INDICATIONS & USAGE

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

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

Keep out of reach of children

If product is swallowed, get medical attention or contact poison control center immediately

DOSAGE & ADMINISTRATION

DIRECTIONS:

• Apply liberally 15 minutes before sun exposure
• Reapply at least every two hours and
• 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:
• Limited 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

INACTIVE INGREDIENT

OTHER INGREDIENTS:

Cananga Odorata (Ylang Ylang) Flower Oil, Caprylyl Glycol, Cetearyl Alcohol, Cetearyl Olivate, Coco Caprylate, Deionized Water, Fragrance, Hexylene Glycol, Panthenol, Phenoxyethanol, Polyhydroxystearic Acid, Silica, Sodium Phytate, Sorbitan Olivate, Stearyl/Octyldodecyl Citrate Crosspolymer, Styrene / Acrylates Copolymer, Tocopherol, Xanthan Gum

OTHER SAFETY INFORMATION

Other Information :

Protect this product from excessive heat and direct sunlight

QUESTIONS

Questions or Comments ?

Visit www.BrightGuard.com

Distributed by Bright Guard LLC, Newport Beach CA 92660

PRINCIPAL DISPLAY PANEL

BRIGHTGUARD NATURAL POUCH LABEL

INGREDIENTS AND APPEARANCE

BRIGHT GUARD NATURAL SPF 30 
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76348-676
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	209 g  in 950 g

Inactive Ingredients
Ingredient Name	Strength
PHYTATE SODIUM (UNII: 88496G1ERL)
XANTHAN GUM (UNII: TTV12P4NEE)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
PANTHENOL (UNII: WV9CM0O67Z)
WATER (UNII: 059QF0KO0R)
SORBITAN OLIVATE (UNII: MDL271E3GR)
YLANG-YLANG OIL (UNII: 8YOY78GNNX)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
COCO-CAPRYLATE (UNII: 4828G836N6)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
CETEARYL OLIVATE (UNII: 58B69Q84JO)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMER (UNII: PN88NW0KPK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76348-676-01	950 g in 1 POUCH; Type 0: Not a Combination Product	08/24/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	08/24/2022

Labeler - Renu Laboratories, LLC (119451815)

Establishment
Name	Address	ID/FEI	Business Operations
Renu Laboratories, LLC		119451815	manufacture(76348-676)