Otc - Active Ingredient
Active Ingredients:
Zinc Oxide 18.9%
Kids Broad Spectrum Spf 35 Cream
FDA Label NDC 62742-4114
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, Llc for the product Kids Broad Spectrum Spf 35 (NDC 62742-4114). 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 - when using, otc - stop use, otc - keep out of reach of children, dosage & administration, 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:
- Provide high protection against sunburn.
- Provide broad spectrum (UVA and UVB) protection.
- If used as directed with other sun protection measures, decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
Warnings: For external use only.
Otc - When Using
Keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop and ask a doctor if rash or irritation occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Dosage & Administration
Directions:
- Apply liberally 15 minutes before sun exposure.
- Reapply: after swimming or sweating. Immediately after towel drying. At least every 2 hours.
- Children under 6 months: Ask a doctor.
Inactive Ingredient
Inactive Ingredients: Caprylic/Capric Triglyceride, Water (Aqua), Glycerin, Polysorbate 60, Stearic Acid, Cetyl Alcohol, Sorbitan Stearate, Cetearyl Glucoside, Stearyl Alcohol, Polyhydroxystearic Acid, Polyglyceryl-3 Ricinoleate, Isostearic Acid, Lecithin, Phenoxyethanol, Xanthan Gum, Carageenan, Helionori, Punica Granatum (Pomegranate) Extract, Plantago Lanceolate (Plantain) Leaf Extract, Ascorbyl Palmitate (Vitamin-C), Ethylhexylglycerin.
Other Safety Information
High sun protection product.
Otc - Questions
Questions? Call toll free 1-800-798-7970
Package Label.Principal Display Panel
Sun Research LLC
Santa Cruz, CA
www.burnoutsun.com
Imgkbsspf35 (Imgkbsspf35)
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