Red Gecko Broad Spectrum Spf 30 Sunscreen
FDA Label NDC 82086-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Formula 7venz L.l.c. for the product Red Gecko Broad Spectrum Spf 30 Sunscreen (NDC 82086-002). 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 drug facts, active ingredient, purpose, uses, warnings, directions, other information, inactive ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Zinc Oxide 18%
Purpose
Sunscreen
Uses
• Helps prevent sunburn.
• If used as directed with other sun protection measures (see Directions), decreases the risk of 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 ask doctor if rash occurs.
Directions
• Apply liberally and evenly 15 minutes prior to sun exposure
• Reapply: After 40 minutes of swimming or sweating · immediately after towel drying · at least every 2 hours
• Children under 6 months of age: Ask a doctor.
Sun Protection Measures : Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly
use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• Limit time in the sun, especially from 10 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses.
Other Information
• Protect this product from excessive heat and direct sun.
Inactive Ingredients
Aloe barbadensis leaf juice, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, helianthus annuus (sunflower) seed
oil, ricinus communis (castor) seed oil, beeswax, oryza sativa (rice) bran wax, sorbitan sesquioleate, glycerin, cetyl alcohol, stearyl
alcohol, magnesium aluminum silicate, butyrospermum parkii (shea) butter, camellia sinensis flower extract, ilex paraguariensis
leaf extract, rosa canina fruit oil, tocopheryl acetate, carthamus tinctorius (safflower) seed oil, rubus idaeus (raspberry) fruit
extract, squalane, xanthan gum, propanediol, ethylhexylglycerin, potassium sorbate.
Questions?
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Packaging
Image (8208600234)
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