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| Product NDC Code | 42851-069 | ||||
|---|---|---|---|---|---|
| Drug Name | Sunscreen plus powder broad-spectrum spf 45 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | POWDER | ||||
| 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 25.0% Sunscreen
| Zinc Oxide 25.0% | 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.Drug Facts Active Ingredients Active Ingredients Purpose Zinc Oxide 25.0% Sunscreen Purpose 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 Reapply: at least every 2 hours Use a water-resistant sunscreen if 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 Sun alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun. Protect the product in this container from excessive heat and direct sun. You may report a serious adverse reaction to: 9685 Research Dr., Irvine, CA 92618 Inactive Ingredients HDI/Trimethylol Hexyllactone Crosspolymer, Simmondsia Chinensis (Jojoba) Butter, Bronze Powder, Simmondsia Chinensis (Jojoba) Seed Oil, Triethoxycaprylylsilane, Bisabolol, Ethyl Ferulate, Ethylhexylglycerin, Melanin, Pentylene Glycol, Water, Silica, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Phenoxyethanol.
| Zinc Oxide 25.0% | Sunscreen |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients HDI/Trimethylol Hexyllactone Crosspolymer, Simmondsia Chinensis (Jojoba) Butter, Bronze Powder, Simmondsia Chinensis (Jojoba) Seed Oil, Triethoxycaprylylsilane, Bisabolol, Ethyl Ferulate, Ethylhexylglycerin, Melanin, Pentylene Glycol, Water, Silica, Tocopheryl Acetate, Ascorbic Acid, Retinyl Palmitate, Phenoxyethanol.
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.Purpose Sunscreen
Directions Apply liberally 15 minutes before sun exposure Reapply: at least every 2 hours Use a water-resistant sunscreen if 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.
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.Sunscreen Plus Powder Broad-Spectrum SPF 45 Zinc Oxide HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER JOJOBA BUTTER COPPER JOJOBA OIL ETHYL FERULATE WATER SILICON DIOXIDE PHENOXYETHANOL .ALPHA.-TOCOPHEROL ACETATE ASCORBIC ACID VITAMIN A PALMITATE LEVOMENOL TRIBASIC CALCIUM PHOSPHATE ETHYLHEXYLGLYCERIN MICA FERRIC OXIDE RED PENTYLENE GLYCOL POLY(METHYL METHACRYLATE; 450000 MW) TRIETHOXYCAPRYLYLSILANE ZINC OXIDE ZINC OXIDE
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 42851-069-27 SUNSCREEN + POWDER BROAD-SPECTRUM SPF 45 ZOX12® DEEP Net Wt. 2.7 g / 0.09 Oz. US Sunscreen + Powder SPF 45 Deep - Unit Carton
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 categorization of Directions to Indications & Usage Section (previously designated the Dosage & Administration Section). Designated the Drug Facts parent with classification of Dosage & Administration. The preceding transmission was accepted without a category.
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Dist. by ZO Skin Health, Inc. Irvine, CA 92618 Made in USA with US & imported materials zoskinhealth.com | 972300
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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.You may report a serious adverse reaction to: 9685 Research Dr., Irvine, CA 92618
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.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. 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