MedPath

Bright Guard Sport SPF

Bright Guard Sport SPF 30

Approved
Approval ID

c9b48a9e-d69f-65a7-e053-2995a90a0baf

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 SPF

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76348-675
Application NumberM020
Product Classification
M
Marketing Category
C200263
G
Generic Name
ZINC SPF
Product Specifications
Route of AdministrationTOPICAL
Effective DateMay 12, 2025
FDA Product Classification

INGREDIENTS (21)

ZINC OXIDEActive
Quantity: 17.5 g in 1000 g
Code: SOI2LOH54Z
Classification: ACTIB
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
POLYOXYL 20 CETOSTEARYL ETHERInactive
Code: YRC528SWUY
Classification: IACT
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
OCTINOXATEActive
Quantity: 70 g in 1000 g
Code: 4Y5P7MUD51
Classification: ACTIB
DIMETHICONE 350Inactive
Code: 2Y53S6ATLU
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
STEARIC ACIDInactive
Code: 4ELV7Z65AP
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ISOCETYL STEARATEInactive
Code: 3RJ7186O9W
Classification: IACT
ALPHA-TOCOPHEROL ACETATEInactive
Code: 9E8X80D2L0
Classification: IACT
TROLAMINEInactive
Code: 9O3K93S3TK
Classification: IACT
ALOE VERA LEAFInactive
Code: ZY81Z83H0X
Classification: IACT
POLYESTER-7Inactive
Code: 0841698D2F
Classification: IACT
NEOPENTYL GLYCOL DIHEPTANOATEInactive
Code: 5LKW3C543X
Classification: IACT
CAPRYLYL GLYCOLInactive
Code: 00YIU5438U
Classification: IACT
PHENOXYETHANOLInactive
Code: HIE492ZZ3T
Classification: IACT
HEXYLENE GLYCOLInactive
Code: KEH0A3F75J
Classification: IACT
TITANIUM DIOXIDEActive
Quantity: 12.5 g in 1000 g
Code: 15FIX9V2JP
Classification: ACTIB
OCTISALATEActive
Quantity: 10 g in 1000 g
Code: 4X49Y0596W
Classification: ACTIB
CARBOMER 934Inactive
Code: Z135WT9208
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/1/2021

Pouch Label

BRIGHT GUARD POUCH LABEL

BRIGHT GUARD SPORT SPF 30 POUCH LABEL

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/1/2021

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: 7/1/2021

Bright Guard Sport SPF 30

sunscreen is broad spectrum, water

resistant (80 minutes), free of parabens

and made for all skin types

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/1/2021

Active Ingredients

Octyl Methoxy Cinnamate 7.00% Sunscreen

Titanium Dioxide 1.25% Sunscreen

Zinc Oxide 1.25% Sunscreen

Octyl Salicylate 1.00% Sunscreen

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/1/2021

Purpose

Octyl Methoxy Cinnamate 7.00% Sunscreen

Titanium Dioxide 1.25% Sunscreen

Zinc Oxide 1.25% Sunscreen

Octyl Salicylate 1.00% Sunscreen

WARNINGS SECTION

LOINC: 34071-1Updated: 7/1/2021

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 physicianif irritation or rash develops.
  • If product is swallowed, get medical attention or contact poison control center immediately.

Keep out of reach of children

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/1/2021

DIRECTIONS

  • Apply generously 15 minutes before sun exposure
  • Reapply after 80 minutes of swimming or sweating.
  • reapply immediately after towel drying.
  • Reapply at least every 2 hours. *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: 7/1/2021

OTHER INGREDIENTS

Aloe Barbadensis (Aloe Vera) Leaf Juice, Caprylyl Glycol, Carbopol, Deionized Water, Ceteareth-20, Cetearyl Alcohol, Dimethicone, Isocetyl Stearate, Polyester-7, Neopentyl Glycol, Diheptanoate, Sorbitol, Stearic Acid, Tocopheryl Acetate (Vitamin E), Triethanolamine.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 7/1/2021

Other information

  • Protect this product from excessive heat and direct sunlight.
  • May stain some fabrics.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 7/1/2021

Questions or Comments?

Visit www.BrightGuard.com or call (310) 589-4116

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 7/20/2021

KEEP OUT OF REACH OF CHILDREN

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Bright Guard Sport SPF - FDA Drug Approval Details