Active Ingredients
Zinc oxide (8%)
Purple Sunblock
FDA Label NDC 71547-111
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Iruri Nature Handmade Soap & Cosmetic Inc for the product Purple Sunblock (NDC 71547-111). 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 ingredients, purpose, uses, warnings, keep out of reach of children, directions, inactive ingredients, purple sunblock (grape seed & argan oil sunblock), 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 when skin is red, inflamed, irritated, or painful
When using this product
- do not apply on other parts of the body
- do not use on damaged or broken skin
- avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water
- do not apply directly to wound or open cut
Stop use and ask a doctor if
- Rash or irritation on skin develops and lasts
Keep Out Of Reach Of Children
If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions
1. Apply the adequate amount on the palm of the hands and pat lightly with the fingertips.
2. Apply liberally 15 minutes before sun exposure.
3. Reapply at least every 2 hours.
4. Use a water-resistant sunscreen if swimming or sweating.
5. 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:
1) Limit time in the sun, especially from 10 a.m.- 2 p.m.
2) Wear long-sleeved shirts, pants, hats, and sunglasses.
6. Children under 6 months of age: ask a doctor
Inactive Ingredients
Castor oil, Grape seed oil, Argan oil, Allantoin, Emulsifying wax, Distilled water, Lavender water, Glycerin, Vitamin E oil, Optiphen plus
* Please review the disclaimer below.
