Zo® Skin Health Smart Tone Broad-spectrum Sunscreen Spf 50

Zo® Skin Health Smart Tone Broad-spectrum Sunscreen Spf 50
SPL v6
SPL
SPL Set ID cda67d41-d063-4936-a6b9-23376304eb42
Route
TOPICAL
Published
Effective Date 2022-04-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octocrylene (100 mg) Avobenzone (30 mg) Homosalate (50 mg) Octisalate
Inactive Ingredients
Glyceryl Monostearate Butyloctyl Salicylate Caprylyl Glycol Butylene Glycol Ethyl Ferulate Tetrahexyldecyl Ascorbate Edetate Disodium Anhydrous Steareth-21 Sunflower Oil Petasites Japonicus Root Pentylene Glycol Alkyl (c12-15) Benzoate Hexylene Glycol Boron Nitride Dimethicone/divinyldimethicone/silsesquioxane Crosspolymer Mica Rosemary Alpha-tocopherol Acetate Tocopherol Ascorbic Acid Vitamin A Palmitate Ethylene Brassylate Poly(methyl Methacrylate; 450000 Mw) Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Coco Glucoside Phenoxyethanol Potassium Sorbate Argan Oil Aluminum Hydroxide Oleyl Alcohol Alcohol Steareth-2 Sodium Hydroxide Ethylhexylglycerin Ferric Oxide Red Water Glycerin Panthenol Triacetate, (+)- Dimethicone Peg-100 Stearate Ethyl Linoleate Peg-8 Laurate Isostearic Acid 1,2-hexanediol Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2022-06-01 Until 2026-11-01
Description

Active Ingredients Purpose Avobenzone 3% ............... Sunscreen Homosalate 10%............... Sunscreen Octisalate 5%................... Sunscreen Octocrylene 10% .............. Sunscreen

Medication Information

Description

Active Ingredients Purpose Avobenzone 3% ............... Sunscreen Homosalate 10%............... Sunscreen Octisalate 5%................... Sunscreen Octocrylene 10% .............. 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
Section 43683-2

Updated Directions section’s classification from Other Safety Information to Indications & Usage.

Designated the Drug Facts parent with classification of Dosage & Administration. Preceding transmission was accepted without a category.

Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Reapply: at least every 2 hours.
  • 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 the product in this container from excessive heat and direct sun.
Active Ingredients
Active Ingredients Purpose
Avobenzone 3% ............... Sunscreen
Homosalate 10%............... Sunscreen
Octisalate 5%................... Sunscreen
Octocrylene 10% .............. Sunscreen

Inactive Ingredients

Water, Dimethicone, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Dimethicone/Divinyldimethicone/Silsesquioxane Crosspolymer, Glyceryl Stearate, Mica, PEG-100 Stearate, Butylene Glycol, Polyamide-5, Steareth-21, Argania Spinosa Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Petasites Japonicus Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopheryl Acetate, Tocopherol, Ascorbic Acid, Retinyl Palmitate, Caprylyl Glycol, Hexylene Glycol, Melanin, Pentylene Glycol, Boron Nitride, Ethyl Ferulate, C12-15 Alkyl Benzoate, Tetrahexyldecyl Ascorbate, Beta-Glucan, Ethylene Brassylate, Polymethyl

Methacrylate, Acrylates/Ammonium Methacrylate Copolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Acrylates Crosspolymer-4, Panthenyl Triacetate, Glycerin, Aluminum Hydroxide, Simethicone, Ethyl Linoleate, Oleyl Alcohol,

Cetearyl Alcohol, PEG-8 Laurate, Steareth-2, Coco-Glucoside, Isostearic Acid, Sodium Hydroxide, Phenoxyethanol, 1,2-Hexanediol, Potassium Sorbate, Ethylhexylglycerin, Fragrance, Titanium Dioxide, Iron Oxides.

Principal Display Panel

ZO® SKIN HEALTH

by ZEIN OBAGI MD

NDC 42851-055-45

Smart Tone Broad-Spectrum Sunscreen SPF 50

ZOX12 ®

Ultra-lightweight sunscreen with customizable color beads designed to blend into most skin tones. Provides broad-spectrum protection against UVA/UVB rays. Natural melanin helps shield skin from the aging effects of high-energy visible (HEV) light. Oxybenzone free.

ZOX12 ®

Engineered with our exclusive 12-hour, time-release ZOX12 ®complex, our sunscreens help shield the skin from harmful infrared (IR-A) rays.

Dist. by ZO Skin Health, Inc. Irvine, CA 92618

Made in USA with US & imported materials

zoskinhealth.com | 973380

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
Section 43683-2 (43683-2)

Updated Directions section’s classification from Other Safety Information to Indications & Usage.

Designated the Drug Facts parent with classification of Dosage & Administration. Preceding transmission was accepted without a category.

Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Use a water-resistant sunscreen if swimming or sweating.
  • Reapply: at least every 2 hours.
  • 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 the product in this container from excessive heat and direct sun.
Active Ingredients
Active Ingredients Purpose
Avobenzone 3% ............... Sunscreen
Homosalate 10%............... Sunscreen
Octisalate 5%................... Sunscreen
Octocrylene 10% .............. Sunscreen

Inactive Ingredients

Water, Dimethicone, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Dimethicone/Divinyldimethicone/Silsesquioxane Crosspolymer, Glyceryl Stearate, Mica, PEG-100 Stearate, Butylene Glycol, Polyamide-5, Steareth-21, Argania Spinosa Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Petasites Japonicus Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopheryl Acetate, Tocopherol, Ascorbic Acid, Retinyl Palmitate, Caprylyl Glycol, Hexylene Glycol, Melanin, Pentylene Glycol, Boron Nitride, Ethyl Ferulate, C12-15 Alkyl Benzoate, Tetrahexyldecyl Ascorbate, Beta-Glucan, Ethylene Brassylate, Polymethyl

Methacrylate, Acrylates/Ammonium Methacrylate Copolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Acrylates Crosspolymer-4, Panthenyl Triacetate, Glycerin, Aluminum Hydroxide, Simethicone, Ethyl Linoleate, Oleyl Alcohol,

Cetearyl Alcohol, PEG-8 Laurate, Steareth-2, Coco-Glucoside, Isostearic Acid, Sodium Hydroxide, Phenoxyethanol, 1,2-Hexanediol, Potassium Sorbate, Ethylhexylglycerin, Fragrance, Titanium Dioxide, Iron Oxides.

Principal Display Panel

ZO® SKIN HEALTH

by ZEIN OBAGI MD

NDC 42851-055-45

Smart Tone Broad-Spectrum Sunscreen SPF 50

ZOX12 ®

Ultra-lightweight sunscreen with customizable color beads designed to blend into most skin tones. Provides broad-spectrum protection against UVA/UVB rays. Natural melanin helps shield skin from the aging effects of high-energy visible (HEV) light. Oxybenzone free.

ZOX12 ®

Engineered with our exclusive 12-hour, time-release ZOX12 ®complex, our sunscreens help shield the skin from harmful infrared (IR-A) rays.

Dist. by ZO Skin Health, Inc. Irvine, CA 92618

Made in USA with US & imported materials

zoskinhealth.com | 973380

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: 2026-02-15T12:04:15.085989 · Updated: 2026-03-14T23:04:51.429622