Active Ingredient
Zinc Oxide (10%)
Sincerely Yours Sunny Side Up Mineral Sunscreen Lotion
FDA Label NDC 87499-101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sincerely Yours Inc. for the product Sincerely Yours Sunny Side Up Mineral Sunscreen (NDC 87499-101). 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, uses, directions, warnings, otc - do not use, otc - when using, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses
- 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.
Directions
- Apply liberally 15 minutes before sun exposure
- 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 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-sleeve shirts, pants, hats, and sunglasses
- Use a water resistant sunscreen if swimming or sweating
- Children under 6 months: Ask a doctor
Warnings
.
Otc - Do Not Use
• For external use only.
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.
Inactive Ingredients
Aqua/Water/Eau, Butylene Glycol, Caprylic/Capric Triglyceride, Dimethicone, Cetearyl Alcohol, Cetearyl Olivate, Polyglyceryl-3 Diisostearate, Sorbitan Olivate, Allantoin, Ceramide NP, Chondrus Crispus Extract, Sodium Hyaluronate, Tocopherol, Cetearyl Glucoside, Triethoxycaprylylsilane, Xanthan Gum, Hydroxyacetophenone, 1,2-Hexanediol, Ethylhexylglycerin, Phenoxyethanol, Iron Oxides (CI 77492).
Questions Or Comments?
www.sincerely-yours.com
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