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| Product NDC Code | 42851-055 | ||||||||
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| Drug Name | Zo skin health smart tone 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 Avobenzone 3% ............... Sunscreen Homosalate 10%............... Sunscreen Octisalate 5%................... Sunscreen Octocrylene 10% .............. Sunscreen
| Avobenzone 3% ............... | Sunscreen |
| Homosalate 10%............... | Sunscreen |
| Octisalate 5%................... | Sunscreen |
| Octocrylene 10% .............. | 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.Drug Facts Active Ingredients Active Ingredients Purpose Avobenzone 3% ............... Sunscreen Homosalate 10%............... Sunscreen Octisalate 5%................... Sunscreen Octocrylene 10% .............. 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 Water, Dimethicone, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Dimethicone/Divinyldimethicone/Silsesquioxane Crosspolymer, Glyceryl Stearate, Mica, PEG-100 Stearate, Butylene Glycol, Polyamide-5, Steareth-21, Argania Spinosa Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Petasites Japonicus Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopheryl Acetate, Tocopherol, Ascorbic Acid, Retinyl Palmitate, Caprylyl Glycol, Hexylene Glycol, Melanin, Pentylene Glycol, Boron Nitride, Ethyl Ferulate, C12-15 Alkyl Benzoate, Tetrahexyldecyl Ascorbate, Beta-Glucan, Ethylene Brassylate, Polymethyl Methacrylate, Acrylates/Ammonium Methacrylate Copolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Acrylates Crosspolymer-4, Panthenyl Triacetate, Glycerin, Aluminum Hydroxide, Simethicone, Ethyl Linoleate, Oleyl Alcohol, Cetearyl Alcohol, PEG-8 Laurate, Steareth-2, Coco-Glucoside, Isostearic Acid, Sodium Hydroxide, Phenoxyethanol, 1,2-Hexanediol, Potassium Sorbate, Ethylhexylglycerin, Fragrance, Titanium Dioxide, Iron Oxides.
| Avobenzone 3% ............... | Sunscreen |
| Homosalate 10%............... | Sunscreen |
| Octisalate 5%................... | Sunscreen |
| Octocrylene 10% .............. | Sunscreen |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Water, Dimethicone, Butyloctyl Salicylate, Styrene/Acrylates Copolymer, Dimethicone/Divinyldimethicone/Silsesquioxane Crosspolymer, Glyceryl Stearate, Mica, PEG-100 Stearate, Butylene Glycol, Polyamide-5, Steareth-21, Argania Spinosa Kernel Oil, Helianthus Annuus (Sunflower) Seed Oil, Petasites Japonicus Root Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Tocopheryl Acetate, Tocopherol, Ascorbic Acid, Retinyl Palmitate, Caprylyl Glycol, Hexylene Glycol, Melanin, Pentylene Glycol, Boron Nitride, Ethyl Ferulate, C12-15 Alkyl Benzoate, Tetrahexyldecyl Ascorbate, Beta-Glucan, Ethylene Brassylate, Polymethyl Methacrylate, Acrylates/Ammonium Methacrylate Copolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium EDTA, Acrylates Crosspolymer-4, Panthenyl Triacetate, Glycerin, Aluminum Hydroxide, Simethicone, Ethyl Linoleate, Oleyl Alcohol, Cetearyl Alcohol, PEG-8 Laurate, Steareth-2, Coco-Glucoside, Isostearic Acid, Sodium Hydroxide, Phenoxyethanol, 1,2-Hexanediol, Potassium Sorbate, Ethylhexylglycerin, Fragrance, Titanium Dioxide, 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.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.
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 Smart Tone Broad-Spectrum Sunscreen SPF 50 Avobenzone, Homosalate, Octisalate, Octocrylene GLYCERYL MONOSTEARATE BUTYLOCTYL SALICYLATE CAPRYLYL GLYCOL BUTYLENE GLYCOL ETHYL FERULATE TETRAHEXYLDECYL ASCORBATE EDETATE DISODIUM ANHYDROUS STEARETH-21 SUNFLOWER OIL PETASITES JAPONICUS ROOT PENTYLENE GLYCOL ALKYL (C12-15) BENZOATE HEXYLENE GLYCOL BORON NITRIDE DIMETHICONE/DIVINYLDIMETHICONE/SILSESQUIOXANE CROSSPOLYMER MICA ROSEMARY ALPHA-TOCOPHEROL ACETATE TOCOPHEROL ASCORBIC ACID VITAMIN A PALMITATE ETHYLENE BRASSYLATE POLY(METHYL METHACRYLATE; 450000 MW) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) COCO GLUCOSIDE PHENOXYETHANOL POTASSIUM SORBATE ARGAN OIL ALUMINUM HYDROXIDE OLEYL ALCOHOL ALCOHOL STEARETH-2 SODIUM HYDROXIDE ETHYLHEXYLGLYCERIN FERRIC OXIDE RED WATER GLYCERIN PANTHENOL TRIACETATE, (+)- DIMETHICONE PEG-100 STEARATE ETHYL LINOLEATE PEG-8 LAURATE ISOSTEARIC ACID 1,2-HEXANEDIOL TITANIUM DIOXIDE OCTOCRYLENE OCTOCRYLENE AVOBENZONE AVOBENZONE HOMOSALATE HOMOSALATE OCTISALATE OCTISALATE
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 42851-055-45 Smart Tone Broad-Spectrum Sunscreen SPF 50 ZOX12 ® Ultra-lightweight sunscreen with customizable color beads designed to blend into most skin tones. Provides broad-spectrum protection against UVA/UVB rays. Natural melanin helps shield skin from the aging effects of high-energy visible (HEV) light. Oxybenzone free. ZOX12 ® Engineered with our exclusive 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 | 973380 ZO® Skin Health Smart Tone Broad-Spectrum Sunscreen SPF 50
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Updated Directions section’s classification from Other Safety Information to Indications & Usage. Designated the Drug Facts parent with classification of Dosage & Administration. Preceding transmission was accepted without a category.
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.
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.
Storage and handling
Information about safe storage and handling of the drug product.Other Information Protect the product in this container from excessive heat and direct sun.
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