Otc - Active Ingredient
Active Ingredients:
Zinc Oxide (18.75%) Non-nanoparticle
Broad Spectrum Spf 30 Sunscreen Lotion
FDA Label NDC 65692-0566
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Raining Rose for the product Broad Spectrum Spf 30 Sunscreen (NDC 65692-0566). 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, purpose:, uses:, warnings:, otc - keep out of reach of children, directions, other information, inactive ingredients, 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
Warnings:
- For external use only
- Do not use on damaged or broken skin
- Stop use and ask a doctor if rash occurs
- When using this product keep out of eyes. Rinse with water to remove.
Otc - Keep Out Of Reach Of Children
Keep out of readh of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally 15 minutes before sun exposure
- Reapply after 80 minutes of swimming or sweating
- Reapply immediately after towel drying
- Reapply at least every 2 hours
- Children under 6 months of age: Ask a doctor
- Limit time in the sun, especially from 10a.m.-2p.m.
- wear long sleeved 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:
Other Information
Protect this product from excessive heat and direct sun.
Inactive Ingredients
Sunflower Oil*, Beeswax*, Jojoba Oil*, Coconut Oil*, Tocopherol (Non-GMO). *Organic
Package Label.Principal Display Panel
Broad Spectrum SPF 30 Sunscreen
Natural Mineral Formula
Water Resistant
(80 minutes)
1.5 fl.oz./44 mL
* Please review the disclaimer below.
