Active Ingredient
Zinc Oxide 11%
Daily Hydrating Mineral Body Sunscreen Cream
FDA Label NDC 87330-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Oak Essentials, Llc for the product Daily Hydrating Mineral Body Sunscreen (NDC 87330-101). 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 active ingredient, purpose, use, 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
Purpose
Sunscreen
Use
- Helps prevent sunburn
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 product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
- apply liberally 15 minutes before sun exposure
- children under 6 months of age: Ask a doctor
- use a water-resistant sunscreen if swimming or sweating
- 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 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 the product in this container from excessive heat and direct sun
Inactive Ingredients
Water (Aqua), Caprylic/Capric Triglyceride, Dimethicone, Butylene Glycol, Silica, Cetearyl Alcohol, Cetearyl Olivate, Sorbitan Olivate, Potassium Cetyl Phosphate, Xylitylglucoside, Caprylyl Glycol, Anhydroxylitol, Cetearyl Glucoside, Palmitic Acid, Triethoxycaprylylsilane, Stearic Acid, Xylitol, Glycerin, Pongamia Pinnata Seed Extract, Caprylhydroxamic Acid, Xanthan Gum, Tocopheryl Acetate, Citric Acid, Bioflavonoids, Glycoproteins, Fructooligosaccharides, Pentylene Glycol, Sodium Olivate, Cyamopsis Tetragonoloba (Guar) Gum, Phytic Acid, Fragrance (Parfum).
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