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| Product NDC Code | 42851-091 | ||||
|---|---|---|---|---|---|
| Drug Name | Zo skin health sheer fluid broad-spectrum sunscreen spf 50 |
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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 Zinc Oxide 22.0% Sunscreen
| Zinc Oxide 22.0% | 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. 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Dimethicone, Water, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Cetyl PEG/PPG-10/1 Dimethicone, Silica, Glycerin, Butylene Glycol, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Polysorbate 20, Dimethicone Crosspolymer, Ethyl Ferulate, Triethoxycaprylylsilane, Bisabolol, Phenoxyethanol, Polymethyl Methacrylate, Caprylyl Glycol, Chlorphenesin, Sodium Chloride, Helianthus Annuus (Sunflower) Seed Oil, Sodium Citrate, Melanin, Pentylene Glycol, 1,2-Hexanediol, Ascorbic Acid, Retinyl Palmitate, Beta-Glucan, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Ethylhexylglycerin, 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 Zinc Oxide 22.0% 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 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. 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. Other Information Protect the product in this container from excessive heat and direct sun. Inactive Ingredients Dimethicone, Water, C12-15 Alkyl Benzoate, Dicaprylyl Carbonate, Cetyl PEG/PPG-10/1 Dimethicone, Silica, Glycerin, Butylene Glycol, Argania Spinosa Kernel Oil, Tocopheryl Acetate, Polysorbate 20, Dimethicone Crosspolymer, Ethyl Ferulate, Triethoxycaprylylsilane, Bisabolol, Phenoxyethanol, Polymethyl Methacrylate, Caprylyl Glycol, Chlorphenesin, Sodium Chloride, Helianthus Annuus (Sunflower) Seed Oil, Sodium Citrate, Melanin, Pentylene Glycol, 1,2-Hexanediol, Ascorbic Acid, Retinyl Palmitate, Beta-Glucan, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopherol, Ethylhexylglycerin, Iron Oxides.
| Zinc Oxide 22.0% | 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 ■ 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 Sheer Fluid Broad-Spectrum Sunscreen SPF 50 Zinc Oxide ETHYL FERULATE SODIUM CHLORIDE SODIUM CITRATE MELANIN SYNTHETIC (TYROSINE, PEROXIDE) PENTYLENE GLYCOL VITAMIN A PALMITATE TOCOPHEROL SILICON DIOXIDE GLYCERIN ARGAN OIL ALPHA-TOCOPHEROL ACETATE POLYSORBATE 20 TRIETHOXYCAPRYLYLSILANE POLY(METHYL METHACRYLATE; 450000 MW) CAPRYLYL GLYCOL CHLORPHENESIN SUNFLOWER OIL ASCORBIC ACID ZINC OXIDE ZINC OXIDE WATER CETYL PEG/PPG-10/1 DIMETHICONE (HLB 4) LEVOMENOL PHENOXYETHANOL ROSEMARY ETHYLHEXYLGLYCERIN DIMETHICONE 1,2-HEXANEDIOL FERRIC OXIDE RED ALKYL (C12-15) BENZOATE BUTYLENE GLYCOL DICAPRYLYL CARBONATE DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)
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 42851-091-50 Sheer Fluid Broad-Spectrum Sunscreen SPF 50 ZOX12® 50 mL / 1.7 Fl. Oz. Mineral fluid sunscreen with a natural, bare-faced finish for all skin types. Antioxidant-rich formula defends skin against environmental aggressors. Provides broad-spectrum protection against UVA/UVB. Natural melanin shields skin from aging effects of high-energy visible (HEV) light. Oxybenzone free. Shake well before dispensing. ZOX12® 12-hour, time-release ZOX12® complex, our sunscreens help shield the skin from harmful infrared (IR-A) rays. Dist. by ZO Skin Health, Inc. Irvine, CA 92618 | Made in USA with US & imported materials zoskinhealth.com | 916700 ZO® Skin Health Sheer Fluid 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.
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