Active Ingredients
| Active Ingredients | Purpose |
| Zinc Oxide 25.0% | Sunscreen |
Sunscreen Plus Powder Broad-spectrum Spf 45 Powder
FDA Label NDC 42851-069
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Zo Skin Health, Inc. for the product Sunscreen Plus Powder Broad-spectrum Spf 45 (NDC 42851-069). 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, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Uses
- Helps prevent sunburn
- Higher SPF gives more sunburn protection
- Provides high protection against 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
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.
Stop Use And Ask A Doctor If
- rash occurs.
Keep Out Of Reach Of Children.
- If swallowed, get medical help or contact a Poison Control Center right away.
Directions
- Apply liberally 15 minutes before sun exposure
- Reapply: at least every 2 hours
- Use a water-resistant sunscreen if swimming or sweating
- Children under 6 months of age: Ask a doctor
- 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
- Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun.
Storage And Handling
- Protect the product in this container from excessive heat and direct sun.
Otc - Questions
- You may report a serious adverse reaction to: 9685 Research Dr., Irvine, CA 92618
Inactive Ingredients
HDI/Trimethylol Hexyllactone Crosspolymer, Simmondsia Chinensis (Jojoba) Butter, Bronze Powder, Simmondsia Chinensis
(Jojoba) Seed Oil, Triethoxycaprylylsilane, Bisabolol, Ethyl Ferulate, Ethylhexylglycerin, Melanin, Pentylene Glycol, Water, Silica, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Phenoxyethanol.
Other
Dist. by ZO Skin Health, Inc. Irvine, CA 92618 Made in USA with US & imported materials zoskinhealth.com | 972300
Principal Display Panel
ZO® SKIN HEALTH
BY ZEIN OBAGI MD
NDC 42851-069-27
SUNSCREEN + POWDER BROAD-SPECTRUM SPF 45
ZOX12®
DEEP
Net Wt. 2.7 g / 0.09 Oz.
* Please review the disclaimer below.
