Otc - Active Ingredient
Active ingredient
Zinc Oxide 21%
Hydrating Mineral Sunscreen Bs Spf30 Cream
FDA Label NDC 62742-4260
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 Hydrating Mineral Sunscreen Bs Spf30 (NDC 62742-4260). 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
Use • 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
Otc - Do Not Use
Do not use on damaged or broken skin
Otc - When Using
When using this product keep out of eyes. 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 swallowed, get medical help or call a Poison Control Center right away.
Dosage & Administration
Directions • apply liberally 15 minutes before sun exposure •reapply at least every 2 hours • children under 6 months: 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 sun-glasses.
Other Safety Information
Other information protect this product from excessive heat and direct sun.
CAUTION:
IF YOU HAVE A KNOWN ALLERGY OR EXPERIENCE SENSITIVITY TO ANY OF THE LIST INGREDIENTS, DISCONTINUE USE. FOR EXTERNAL USE ONLY, DO NOT APPLY TO OPEN WOUNDS.
Inactive Ingredient
Inactive ingredients: Water (Aqua), Caprylic/Capric Triglyceride, Coconut Alkanes, Cetearyl Alcohol, Glycerin, Aloe Barbadensis Leaf Juice, Argania Spinosa Kernel Oil, Glyceryl Caprylate, Coco-Glucoside, Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Honey, Avena sativa (Oat) Kernel Flour, Sodium Phytate, Caprylyl/Capryl Glucoside, Xanthan Gum, Dipotassium Glycyrrhizate, Sclerotium Gum, Cetearyl Glucoside, Butyrospermum Parkii (Shea) Butter, Tocopherol, Coco-Caprylate/Caprate, Caprylhydroxamic acid, Sucrose, Spirulina Maxima Extract, Phaeodactylum Tricornutum Extract, Oryza Sativa Starch, Bisabolol,Lecithin, Polyhydroxystearic acid, Polyglyceryl-3 Polyricinoleate, Isostearic acid, Beta-Sitosterol, Squalene, Glucose, C8 Alcohol, C10 Alcohol
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