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Bright Guard Natural SPF 30

Bright Guard Natural SPF 30

Approved
Approval ID

e7035fcd-6894-3360-e053-2a95a90a6f1d

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 12, 2025

Manufacturers
FDA

Renu Laboratories, LLC

DUNS: 119451815

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Zinc Oxide

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76348-676
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
Zinc Oxide
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 12, 2025
FDA Product Classification

INGREDIENTS (18)

PHYTATE SODIUMInactive
Code: 88496G1ERL
Classification: IACT
XANTHAN GUMInactive
Code: TTV12P4NEE
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
PANTHENOLInactive
Code: WV9CM0O67Z
Classification: IACT
YLANG-YLANG OILInactive
Code: 8YOY78GNNX
Classification: IACT
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000)Inactive
Code: 5Z4DPO246A
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
HEXYLENE GLYCOLInactive
Code: KEH0A3F75J
Classification: IACT
ZINC OXIDEActive
Quantity: 209 g in 950 g
Code: SOI2LOH54Z
Classification: ACTIB
COCO-CAPRYLATEInactive
Code: 4828G836N6
Classification: IACT
POLYHYDROXYSTEARIC ACID (2300 MW)Inactive
Code: YXH47AOU0F
Classification: IACT
CETEARYL OLIVATEInactive
Code: 58B69Q84JO
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITAN OLIVATEInactive
Code: MDL271E3GR
Classification: IACT
STEARYL/OCTYLDODECYL CITRATE CROSSPOLYMERInactive
Code: PN88NW0KPK
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 8/24/2022

BRIGHTGUARD NATURAL POUCH LABEL

POUCH LABEL

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 8/24/2022

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.

STATEMENT OF IDENTITY SECTION

LOINC: 69718-5Updated: 8/24/2022

Bright Guard Natural SPF 30

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 8/24/2022

Active Ingredients

Zinc Oxide 22%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 8/24/2022

Purpose

Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 8/24/2022

WARNINGS:

  • For external use only *Do not useon damaged or broken skin *When using this productkeep out of eyes· Rinse with water to remove *Stop use and consult physician ifirritation 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 SECTION

LOINC: 34068-7Updated: 8/24/2022

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 SECTION

LOINC: 51727-6Updated: 8/24/2022

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

LOINC: 60561-8Updated: 8/24/2022

Other Information :

Protect this product from excessive heat and direct sunlight

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 8/24/2022

Questions or Comments ?

Visit www.BrightGuard.com

Distributed by Bright Guard LLC, Newport Beach CA 92660

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