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| Product NDC Code | 42851-095 | ||||||||
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| Drug Name | Zo skin health daily sheer broad-spectrum sunscreen spf 50 water resistant (40 minutes) |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | CREAM | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | ZO Skin Health, Inc. | ||||||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Active Ingredients Purpose Avobenzone 3.0%............. Sunscreen Homosalate 6.8% ............. Sunscreen Octisalate 5.0%................ Sunscreen Octocrylene 10.0% ........... Sunscreen
| Avobenzone 3.0%............. | Sunscreen |
| Homosalate 6.8% ............. | Sunscreen |
| Octisalate 5.0%................ | Sunscreen |
| Octocrylene 10.0% ........... | Sunscreen |
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Drug Facts Active Ingredients 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. Do not use ■ on damaged or broken skin. 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. 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.
| Avobenzone 3.0%............. | Sunscreen |
| Homosalate 6.8% ............. | Sunscreen |
| Octisalate 5.0%................ | Sunscreen |
| Octocrylene 10.0% ........... | Sunscreen |
Purpose
Information about the drug product’s indications for use.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
Spl product data elements
Usually a list of ingredients in a drug product.ZO Skin Health Daily Sheer Broad-Spectrum Sunscreen SPF 50 Water Resistant (40 Minutes) Avobenzone, Homosalate, Octisalate, Octocrylene 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 HOMOSALATE HOMOSALATE OCTOCRYLENE OCTOCRYLENE OCTISALATE OCTISALATE AVOBENZONE AVOBENZONE
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.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. Daily Sheer Broad-Spectrum Sunscreen SPF 50
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use ■ on damaged or broken skin.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. ■ If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information ■ Protect this product from excessive heat and direct sun.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if ■ rash occurs.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product ■ keep out of eyes. Rinse with water to remove.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings For external use only. Do not use ■ on damaged or broken skin. 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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API