Active Ingredients
| Active Ingredients | Purpose |
| Avobenzone 3.0%......... | Sunscreen |
| Octisalate 5.0%............ | Sunscreen |
| Octocrylene 10.0% | Sunscreen |
Zo Skin Health Gel Sunscreen Broad-spectrum Spf 50 Gel
FDA Label NDC 42851-092
11 label sections · Submitted to the FDA by Zo Skin Health, Inc. · 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 Zo Skin Health Gel Sunscreen Broad-spectrum Spf 50 (NDC 42851-092). 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. ■ after 40 minutes of 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
Protect this product from excessive heat and direct sun.
Inactive Ingredients
Isododecane, Silica, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Ethylhexyl Palmitate, Caprylic/Capric Triglyceride, Polyamide-8, Polyester-8, Isodecyl Neopentanoate, Polyamide-3, Dimethicone/Bis-Isobutyl PPG-20 Crosspolymer, Polymethylsilsesquioxane/Trimethylsiloxysilicate, Diethylhexyl 2,6-Naphthalate, Diisopropyl Sebacate, Lauryl Lactate, Hydrogenated Poly(C6-20 Olefin), Bisabolol, Lupinus Albus Seed Oil, Triticum Vulgare (Wheat) Germ Extract, Glycine Soja (Soybean) Oil, Leontopodium Alpinum Meristem Cell Culture, Marrubium Vulgare Meristem Cell Culture, Tocopherol, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Melanin, Pentylene Glycol, Lecithin, Caprylyl Glycol, Glycerin, Diethylhexyl Syringylidenemalonate, HDI/Trimethylol Hexyllactone Crosspolymer, Polymethyl Methacrylate, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Water, Ethylhexylglycerin
Principal Display Panel
ZO® Skin Health Gel Sunscreen Broad-Spectrum SPF 50
Water-Resistant
(40 Minutes)
ZOX12®
Triple-Spectrum Protection™
Protection against UVA+UVB, blue light (HEV),
and Infrared-A (IR-A) rays.
ZOX12®
Time-released antioxidant complex delivers
up to 12 hours of environmental protection.
Dist. by ZO Skin Health, Inc. Irvine, CA 92618
Made in USA with US & imported materials
zoskinhealth.com
* Please review the disclaimer below.
