Statement Of Identity
IMPACT MELANOMA SPF 30
sunscreen is broad spectrum, water
resistant (80 minutes), free of parabens
and made for all skin types
Impact Melanoma Spf 30 Lotion
FDA Label NDC 76348-598
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 Impact Melanoma Spf 30 (NDC 76348-598). 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, active ingredients, purpose, uses, warnings, directions, other ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients
Octyl Methoxy Cinnamate 7.00% Sunscreen
Titanium Dioxide 1.25% Sunscreen
Zinc Oxide 1.25% Sunscreen
Octyl Salicylate 1.00% Sunscreen
Purpose
Octyl Methoxy Cinnamate 7.00% Sunscreen
Titanium Dioxide 1.25% Sunscreen
Zinc Oxide 1.25% Sunscreen
Octyl Salicylate 1.00% Sunscreen
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
- 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 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.
Other Ingredients
Aloe Barbadensis (Aloe Vera) Leaf Juice, Calendula Officinalis (Marigold) Flower Extract, Caprylyl Glycol, Carbopol, Ceteareth-20, Cetearyl Alcohol, Deionized Water, Dimethicone, Glycerin, Hexylene Glycol, Isocetyl Stearate, Malva Sylvestris (Mallow) Flower Extract, Panax Ginseng Root Extract, Phenoxyethanol, Polyester-7, Neopentyl Glycol, Diheptanoate, Sorbitol, Stearic Acid,
Symphytum Officinale (Comfrey) Leaf Extract, Triethanolamine, Tocopheryl Acetate (Vitamin E)
Other Information
- Protect this product from excessive heat and direct sunlight.
- May stain some fabrics.
Questions Or Comments?
Visit www.BrightGuard.com or call (310) 589-4116
Recent Major Changes
Minor word changes in Administration such as apply liberally rather than apply generously
No Major changes in Uses section
Package Label.Principal Display Panel
LABEL FOR IMPACT MELANOMA SPF
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