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

Warnings

For external use only.

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

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

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.

Description

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

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.

Do Not Use

■ on damaged or broken skin.

Active Ingredients

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

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

Warnings

For external use only.

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

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

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.

Do Not Use (Do not use)

■ on damaged or broken skin.

Active Ingredients

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

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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