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| Product NDC Code | 42851-094 | ||||||||
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| Drug Name | Zo skin health daily sheer broad-spectrum sunscreen spf 45 |
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| Type | Brand | ||||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||||
| Dosage Form | LOTION | ||||||||
| Application Number | M020 | ||||||||
| Labeler Name | ZO Skin Health, Inc. | ||||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
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, Glyceryl Stearate, PEG-100 Stearate, Tocopheryl Acetate, 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 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.
| 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 45 Avobenzone, Homosalate, Octisalate, Octocrylene LEVOMENOL ROSEMARY DIMETHICONE 100 PHENOXYETHANOL CETEARYL GLUCOSIDE EDETATE DISODIUM ANHYDROUS POLY(METHYL METHACRYLATE; 450000 MW) FERRIC OXIDE RED ETHYL FERULATE HOMOSALATE HOMOSALATE ISODODECANE ARGAN OIL GLYCERYL STEARATE SE PEG-100 STEARATE ALPHA-TOCOPHEROL ACETATE GLYCERIN PROPANEDIOL ETHYLHEXYLGLYCERIN AVOBENZONE AVOBENZONE WATER 1,2-HEXANEDIOL STEARETH-21 MELANIN SYNTHETIC (TYROSINE, PEROXIDE) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (45000 MPA.S AT 1%) SUNFLOWER OIL OCTISALATE OCTISALATE OCTOCRYLENE OCTOCRYLENE CETOSTEARYL ALCOHOL DIETHYLHEXYL 2,6-NAPHTHALATE STEARETH-2 POLYSORBATE 60 SILICON DIOXIDE ASCORBIC ACID BUTYLOCTYL SALICYLATE SODIUM HYDROXIDE PENTYLENE GLYCOL VITAMIN A PALMITATE SQUALANE TOCOPHEROL GLYCYRRHIZINATE DIPOTASSIUM SODIUM C14-16 OLEFIN SULFONATE
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 42851-094-45 DAILY SHEER BROAD-SPECTRUM SUNSCREEN SPF 45 WATER RESISTANT (40 Minutes) ZOX12® Engineered with our exclusive 12-hour, time-release ZOX12® complex, our sunscreens help shield the skin from harmful infrared (IR-A) rays. Non-greasy, quick-drying sunscreen with a sheer matte finish offering broad-spectrum protection against UVA/UVB rays. Natural melanin shields skin from aging effects of high-energy visible (HEV) light. Water and perspiration resistant, this sunscreen delivers superior protection during outdoor activities while hydrating the skin to prevent dryness. Oxybenzone free. Dist. by ZO Skin Health, Inc. Irvine, CA 92618 Made in USA with US & imported materials ZO Skin Health 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 the product in this container from excessive heat and direct sun.
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.
Stop use and ask a doctor if rash occurs.
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.
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