Zo® Skin Health Daily Sheer Broad-spectrum Sunscreen Spf 50 Water Resistant (40 Minutes)

Zo® Skin Health Daily Sheer Broad-spectrum Sunscreen Spf 50 Water Resistant (40 Minutes)
SPL v3
SPL
SPL Set ID fd7d40fe-178a-e1b1-e053-6294a90a29a1
Route
TOPICAL
Published
Effective Date 2023-07-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (3060 mg) Octocrylene (4500 mg) Octisalate (2250 mg) Avobenzone (1350 mg)
Inactive Ingredients
Pentylene Glycol 1,2-hexanediol Ferric Oxide Red Water Silicon Dioxide Triacontanyl Pvp (wp-660) Argan Oil Peg-100 Stearate Glycerin Sunflower Oil Ascorbic Acid Squalane Cetearyl Glucoside Steareth-2 Polysorbate 60 Hydroxyethyl Acrylate/sodium Acryloyldimethyl Taurate Copolymer (45000 Mpa.s At 1%) Sodium Hydroxide Ethylhexylglycerin Phenoxyethanol Propanediol Rosemary Tocopherol Vitamin A Palmitate Melanin Synthetic (tyrosine, Peroxide) Poly(methyl Methacrylate; 450000 Mw) Edetate Disodium Anhydrous Sodium C14-16 Olefin Sulfonate .alpha.-tocopherol Acetate Glyceryl Monostearate Isododecane Glycyrrhizinate Dipotassium Ethyl Ferulate Levomenol Steareth-21 Dimethicone Cetostearyl Alcohol Butyloctyl Salicylate Diethylhexyl 2,6-naphthalate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-10-01

Description

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


Medication Information

Description

Active 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

■ retains SPF after 40 minutes of perspiring

■ 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
Homosalate 6.8% ............. Sunscreen
Octisalate 5.0%................ Sunscreen
Octocrylene 10.0% ........... Sunscreen

Inactive Ingredients

Water, Butyloctyl Salicylate, Silica, Dimethicone, Cetearyl Alcohol, Diethylhexyl 2,6-Naphthalate, Triacontanyl PVP, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Glyceryl Stearate, PEG-100 Stearate, Isododecane, Glycerin, Bisabolol, Propanediol, Steareth-21, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Ascorbic Acid, Retinyl Palmitate, Dipotassium Glycyrrhizate, Squalane, Beta-Glucan, Melanin, Cetearyl Glucoside, Steareth-2, Polysorbate 60, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates Copolymer, Polymethyl Methacrylate, Disodium EDTA, Ethyl Ferulate, Sodium C14-16 Olefin Sulfonate, Sodium Hydroxide, Phenoxyethanol, Ethylhexylglycerin, Pentylene Glycol, 1,2-Hexanediol, Fragrance, Iron Oxides.

Principal Display Panel

ZO® Skin Health

by Zein Obagi MD

NDC 42851-095-45

Daily Sheer Broad-Spectrum Sunscreen SPF 50

Water Resistant

(40 Minutes)

ZOX12®

45 mL / 1.5 Fl. Oz.

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

■ retains SPF after 40 minutes of perspiring

■ 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
Homosalate 6.8% ............. Sunscreen
Octisalate 5.0%................ Sunscreen
Octocrylene 10.0% ........... Sunscreen

Inactive Ingredients

Water, Butyloctyl Salicylate, Silica, Dimethicone, Cetearyl Alcohol, Diethylhexyl 2,6-Naphthalate, Triacontanyl PVP, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Glyceryl Stearate, PEG-100 Stearate, Isododecane, Glycerin, Bisabolol, Propanediol, Steareth-21, Helianthus Annuus (Sunflower) Seed Oil, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Ascorbic Acid, Retinyl Palmitate, Dipotassium Glycyrrhizate, Squalane, Beta-Glucan, Melanin, Cetearyl Glucoside, Steareth-2, Polysorbate 60, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Acrylates Copolymer, Polymethyl Methacrylate, Disodium EDTA, Ethyl Ferulate, Sodium C14-16 Olefin Sulfonate, Sodium Hydroxide, Phenoxyethanol, Ethylhexylglycerin, Pentylene Glycol, 1,2-Hexanediol, Fragrance, Iron Oxides.

Principal Display Panel

ZO® Skin Health

by Zein Obagi MD

NDC 42851-095-45

Daily Sheer Broad-Spectrum Sunscreen SPF 50

Water Resistant

(40 Minutes)

ZOX12®

45 mL / 1.5 Fl. Oz.

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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