SPL v2
SPL
SPL Set ID 1560a6b6-8d4a-6942-e063-6294a90a4a44
Route
TOPICAL
Published
Effective Date 2024-04-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (50 mg) Avobenzone (30 mg) Octocrylene (100 mg) Homosalate (68 mg)
Inactive Ingredients
Peg-100 Stearate Caprylyl Glycol Propylene Glycol Stearate Cetostearyl Alcohol Ethyl Ferulate Phenoxyethanol Ethyl Linoleate Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Magnesium Stearate 1,2-hexanediol Titanium Dioxide Ferric Oxide Red Ethylhexylglycerin Tetrahexyldecyl Ascorbate Cellulose Acetate Sodium Hydroxide Ethylene Brassylate Peg-8 Laurate Oleyl Alcohol Acrylates Crosspolymer-4 Panthenol Triacetate, (+)- Petasites Japonicus Root Butyloctyl Salicylate Ascorbic Acid Mica Steareth-21 Rosemary .alpha.-tocopherol Acetate Vitamin A Palmitate Hexylene Glycol Melanin Synthetic (tyrosine, Peroxide) Pentylene Glycol Glycerin Coco-glucoside Steareth-2 Poly(methyl Methacrylate; 450000 Mw) Edetate Disodium Potassium Sorbate Water Polyamide-5 Argan Oil Sunflower Oil Tocopherol Dimethicone/divinyldimethicone/silsesquioxane Crosspolymer Butylene Glycol Dimethicone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-19

Description

Ingredients Purpose Avobenzone 3.0%............. Sunscreen Homosalate 6.8%............. Sunscreen Octisalate 5.0%................ Sunscreen Octocrylene 10.0%................ Sunscreen


Medication Information

Description

Ingredients Purpose Avobenzone 3.0%............. Sunscreen Homosalate 6.8%............. 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
Section 51945-4

ZO® SKIN HEALTH

by ZEIN OBAGI MD

NDC 42851-096-45

Smart Tone Broad-Spectrum Sunscreen SPF 50

ZOX12 ®

45 mL / 1.5 Fl. Oz.

Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure and as needed.
  • 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
  • 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.
  • Protect this product from excessive heat and direct sun.
Active Ingredients
Ingredients Purpose
Avobenzone 3.0%............. Sunscreen
Homosalate 6.8%............. Sunscreen
Octisalate 5.0%................ Sunscreen
Octocrylene 10.0%................ Sunscreen

Inactive Ingredients

Water, Dimethicone, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Dimethicone/Divinyldimethicone/Silsesquioxane Crosspolymer, Glyceryl Stearate, PEG-100 Stearate, Butylene Glycol, Mica, Polyamide-5, Steareth-21, Argania Spinosa Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Petasites Japonicus Root Extract, Tocopheryl Acetate, Tocopherol, Ascorbic Acid, Retinyl Palmitate, Caprylyl Glycol, Hexylene Glycol, Propylene Glycol Stearate, Melanin, Pentylene Glycol, Tetrahexyldecyl Ascorbate, Beta-Glucan, Glycerin, Ethyl Linoleate, Oleyl Alcohol, Acrylates Crosspolymer-4, Dimethicone/Vinyl Dimethicone Crosspolymer, Magnesium Stearate, Panthenyl Triacetate, Cetearyl Alcohol, PEG-8 Laurate, Coco-Glucoside, Steareth-2, Polymethyl Methacrylate, Cellulose Acetate,Acrylates/Ammonium Methacrylate Copolymer, Simethicone, Disodium EDTA, Sodium Hydroxide, Ethyl Ferulate, Phenoxyethanol, 1,2-Hexanediol, Potassium Sorbate, Ethylhexylglycerin, Ethylene Brassylate, Fragrance, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, 77492, 77499).

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 51945-4 (51945-4)

ZO® SKIN HEALTH

by ZEIN OBAGI MD

NDC 42851-096-45

Smart Tone Broad-Spectrum Sunscreen SPF 50

ZOX12 ®

45 mL / 1.5 Fl. Oz.

Warnings

For external use only.

Directions
  • Apply liberally 15 minutes before sun exposure and as needed.
  • 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
  • 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.
  • Protect this product from excessive heat and direct sun.
Active Ingredients
Ingredients Purpose
Avobenzone 3.0%............. Sunscreen
Homosalate 6.8%............. Sunscreen
Octisalate 5.0%................ Sunscreen
Octocrylene 10.0%................ Sunscreen

Inactive Ingredients

Water, Dimethicone, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Dimethicone/Divinyldimethicone/Silsesquioxane Crosspolymer, Glyceryl Stearate, PEG-100 Stearate, Butylene Glycol, Mica, Polyamide-5, Steareth-21, Argania Spinosa Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Petasites Japonicus Root Extract, Tocopheryl Acetate, Tocopherol, Ascorbic Acid, Retinyl Palmitate, Caprylyl Glycol, Hexylene Glycol, Propylene Glycol Stearate, Melanin, Pentylene Glycol, Tetrahexyldecyl Ascorbate, Beta-Glucan, Glycerin, Ethyl Linoleate, Oleyl Alcohol, Acrylates Crosspolymer-4, Dimethicone/Vinyl Dimethicone Crosspolymer, Magnesium Stearate, Panthenyl Triacetate, Cetearyl Alcohol, PEG-8 Laurate, Coco-Glucoside, Steareth-2, Polymethyl Methacrylate, Cellulose Acetate,Acrylates/Ammonium Methacrylate Copolymer, Simethicone, Disodium EDTA, Sodium Hydroxide, Ethyl Ferulate, Phenoxyethanol, 1,2-Hexanediol, Potassium Sorbate, Ethylhexylglycerin, Ethylene Brassylate, Fragrance, Titanium Dioxide (CI 77891), Iron Oxides (CI 77491, 77492, 77499).

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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