Otc - Active Ingredient
ACTIVE INGREDIENTS:
Zinc Oxide – 18.6 %
Tropical Topical Matte Spf30 Cream
FDA Label NDC 62742-4231
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Allure Labs for the product Tropical Topical Matte Spf30 (NDC 62742-4231). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - stop use, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Purpose: Sunscreen
Indications & Usage
Uses: Helps prevent sunburn. If used as directed with other sun protection measures, this product decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
Warning:
For external use only
Otc - Do Not Use
Do not use on damage or broken skin.
Otc - When Using
When using this product keep out of eye. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children if product is swallowed, get medical help or contact a poison control center right away.
Dosage & Administration
Direction:
Apply liberally 15 minutes before sun exposure.
Children under 6 month of age: Ask a doctor
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 decreases 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 am – 2.0 pm, Wear long – sleeved shirts, pants, hats and sunglasses.
Other Safety Information
Other Information:
Protect the product in this container from excessive heat and direct sun.
Inactive Ingredient
INACTIVE INGREDIENT: Water, Cyclopentasiloxane, Butylene Glycol, Glycerin, Cyclohexasiloxane, Glyceryl Stearate, PEG-100 Stearate, Polyglyceryl-3 Polydimethylsiloxyethyl, Dimethicone, Sorbitan Stearate, Cetyl Alcohol, Teprenone, Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Caprylic/Capric Triglyceride, Imperata Cylendrica Root Extract, Arabidopsis Thaliana Extract, Plankton Extract, Micrococcus Lysate, Phoenix Dactylifera (Date) Fruit Extract, Polygonum Aviculare Extract, Sodium Lactate, Lecithin, Dipotassium Glycyrrhizate, Tocopheryl Linoleate/ Oleate, Citric Acid, Polyacrylamide, Phenoxyethanol, Caprylyl Glycol, Ethylhexylglycerine, Hexylene Glycol, Xanthan Gum, C13-14 Isoparaffin, Laureth-7, PEG-8, Carbomer, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Tocopherol, Asccorbyl Palmitate, Ascorbc Acid, Fragrance, Disodium EDTA.
Package Label.Principal Display Panel
Tropicaltopicalmatte Spf30 (Tropicaltopicalmattespf30)
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