Otc - Active Ingredient
Active ingredient Purpose
Zinc Oxide 14.57% Sunscreen
Sunscreen Broad Spectrum Spf 30 Light Tropical Scent Cream
FDA Label NDC 56152-0101
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Cosmetic Enterprises Ltd for the product Sunscreen Broad Spectrum Spf 30 Light Tropical Scent (NDC 56152-0101). 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, otc - keep out of reach of children, indications & usage, warnings, dosage & administration, inactive ingredient, other safety information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
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.
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.
Indications & Usage
Stop use and ask a doctor if rash occurs.
Warnings
Warnings
For External use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Dosage & Administration
Directions
- Apply liberally 15 minutes before sun exposure
- Reapply
- After 40 minutes of swimming or sweating .
- Immediately after towel drying
- 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:
- limited time in the sun, especially from 10 a.m. - 2 p.m.
- wear long-sleeve shirts, pants, hats and sunglasses.
- Children under 6 months: ask a doctor
Inactive Ingredient
Inactive Ingredients
Organic High Oleic Sunflower Oil, Organic Coconut Oil, Beeswax, Organic Shea Butter, Tocopherols, Fragrance (All Natural), Carrot Seed Oil.
Other Safety Information
Other information
- Protect this product from excessive heat and direct sun
Package Label.Principal Display Panel
Herban Roots
Chemical Free
Sunscreen Broad Spectrum SPF 30
Water resistant (80 minutes)
Safe for the Whole Family
Sheer, Non-Greasy Coverage
Light Tropical Scent
4.0 FL OZ (118 mL)
* Please review the disclaimer below.
