Zo® Skin Health Gel Sunscreen Broad-spectrum Spf 50

Zo® Skin Health Gel Sunscreen Broad-spectrum Spf 50
SPL v4
SPL
SPL Set ID ec8386f2-9cb7-40f4-e053-2995a90ac2d8
Route
TOPICAL
Published
Effective Date 2022-11-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (4.5 g) Avobenzone (1.35 g) Octisalate (2.25 g)
Inactive Ingredients
Silicon Dioxide Alkyl (c12-15) Benzoate Ethylhexyl Palmitate Isododecane Polyamide-8 (4500 Mw) Polyester-8 (1400 Mw, Cyanodiphenylpropenoyl Capped) Diisopropyl Sebacate Hexamethylene Diisocyanate/trimethylol Hexyllactone Crosspolymer Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) Water Diethylhexyl Syringylidenemalonate Tocopherol Dimethicone/bis-isobutyl Ppg-20 Crosspolymer Wheat Germ Lecithin, Soybean Glycerin Diethylhexyl 2,6-naphthalate Polyamide-3 (12000 Mw) Butyloctyl Salicylate Medium-chain Triglycerides Poly(methyl Methacrylate; 450000 Mw) Ethylhexylglycerin Isodecyl Neopentanoate Polymethylsilsesquioxane/trimethylsiloxysilicate Lauryl Lactate Caprylyl Glycol Pentylene Glycol Lupinus Albus Seed Oil Soybean Oil Alpha-tocopherol Acetate Hydrogenated C6-20 Polyolefin (100 Cst) Levomenol Ascorbic Acid Vitamin A Palmitate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-10-30
Description

Active Ingredients Purpose Avobenzone 3.0%......... Sunscreen Octisalate 5.0%............ Sunscreen Octocrylene 10.0% Sunscreen

Medication Information

Description

Active Ingredients Purpose Avobenzone 3.0%......... Sunscreen Octisalate 5.0%............ Sunscreen Octocrylene 10.0% Sunscreen

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.

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.
Do Not Use
  • on damaged or broken skin.
Other Information

Protect this product from excessive heat and direct sun.

Active Ingredients
Active Ingredients Purpose
Avobenzone 3.0%......... Sunscreen
Octisalate 5.0%............ Sunscreen
Octocrylene 10.0% Sunscreen

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

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.

Structured Label Content

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.

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.
Do Not Use (Do not use)
  • on damaged or broken skin.
Other Information

Protect this product from excessive heat and direct sun.

Active Ingredients
Active Ingredients Purpose
Avobenzone 3.0%......... Sunscreen
Octisalate 5.0%............ Sunscreen
Octocrylene 10.0% Sunscreen

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

When Using This Product (When using this product)
  • keep out of eyes. Rinse with water to remove.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rash occurs.
Keep Out of Reach of Children. (Keep out of reach of children.)
  • If swallowed, get medical help or contact a Poison Control Center right away.

Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:30.798653 · Updated: 2026-03-14T23:11:04.312793