Otc - Active Ingredient
Zinc Oxide 20.00%
Spf 50 Mineral Sunscreen Face And Body Lotion
FDA Label NDC 85865-002
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Toddle Born Wild, Inc. for the product Spf 50 Mineral Sunscreen Face And Body (NDC 85865-002). 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 otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - when using, otc - keep out of reach of children, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Sunscreen
Indications & Usage
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
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 - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Dosage & Administration
Apply evenly to face and neck 15 minutes beofre sun exposure.
Reapply:
- After 40 minutes of swimming or sweating.
- Immediately after towel drying
- At least every 2 hours.
- Limin time in the sun, especially from 10a.m - 2p.m
- Wear long-sleeve shirts, pants, hats, and sunglasses.
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:
Children under 6 months:Ask a doctor.
Other Safety Information
Protect this product from excessive heat and direct sun.
Inactive Ingredient
Aloe Barbadensis Leaf Juice
Butylene Glycol
Butyloctyl Salicylate
Caprylic/Capric Triglyceride
Cetearyl Olivate
Dicaprylyl Carbonate
Dimethicone
Ethylhexyl Methoxycrylene
Ethylhexylglycerin
Helianthus Annuus (Sunflower) Seed Oil
Hydrogenated Castor Oil
Inulin
Isopropyl Myristate
Magnesium Sulfate
Niacinamide
Phenoxyethanol
Polyglyceryl-3 Polyricinoleate
Polyhydroxystearic Acid
Sorbitan Oleate
Sorbitan Olivate
Synthetic Beeswax
Tocopheryl Acetate
VP/Hexadecene Copolymer
Water
Xanthan Gum
Otc - Questions
Questions?
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