Statement Of Identity
Bright Guard Natural SPF 30
Bright Guard Natural Spf 30 Lotion
FDA Label NDC 76348-676
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Renu Laboratories, Llc for the product Bright Guard Natural Spf 30 (NDC 76348-676). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding statement of identity, otc - active ingredient, purpose, indications & usage, warnings, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
Otc - Keep Out Of Reach Of Children
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
Otc - Questions
Questions or Comments ?
Visit www.BrightGuard.com
Distributed by Bright Guard LLC, Newport Beach CA 92660
Package Label.Principal Display Panel
BRIGHTGUARD NATURAL POUCH LABEL
* Please review the disclaimer below.
