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Product NDC Code | 73369-1401 | ||||
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Drug Name | Erins faces mineral spf 32 sunscreen |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | M020 | ||||
Labeler Name | Kabana Skin Care | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredients Zinc Oxide USP** 25%
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.apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply: after swimming or sweating immediately after towel drying at least every 2 hours. 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 AM – 2 PM. Wear long-sleeved shirts, pants, hats and sunglasses. Children under 6 months. Ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aqua (Eldorado Springs Artesian water), Olea Europaea (Olive) Fruit Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, vegetable Glycerine, Butyrospermum Parkii (Shea) Butter*, Vegetable Emulsifying Wax NF, Tocopherol (Vitamin E). *Organic Ingredients
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.Use helps prevent sunburn Keep out of the reach of children. If ingested, consult a Poison Control Center Immediately.
Purpose
Information about the drug product’s indications for use.Purpose Sunscreen
Spl product data elements
Usually a list of ingredients in a drug product.Erins Faces Mineral SPF 32 Sunscreen Zinc Oxide Sunscreen JOJOBA OIL CETOSTEARYL ALCOHOL POLYSORBATE 60 ZINC OXIDE ZINC OXIDE ALPHA-TOCOPHEROL WATER GLYCERIN SHEA BUTTER OLIVE OIL
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.DRUG FACTS erins faces sunscreen Active Ingredients Zinc Oxide USP** 25% Purpose Sunscreen Use helps prevent sunburn Keep out of the reach of children. If ingested, consult a Poison Control Center Immediately. Warnings For external use only Do not use o n 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 apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating reapply: after swimming or sweating immediately after towel drying at least every 2 hours. 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 AM – 2 PM. Wear long-sleeved shirts, pants, hats and sunglasses. Children under 6 months. Ask a doctor Directions Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours 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 AM – 2 PM. wear long-sleeved shirts, pants, hats and sunglasses. Use a water resistant sunscreen if swimming or sweating Children under 6 months. Ask a doctor Inactive Ingredients Aqua (Eldorado Springs Artesian water), Olea Europaea (Olive) Fruit Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, vegetable Glycerine, Butyrospermum Parkii (Shea) Butter*, Vegetable Emulsifying Wax NF, Tocopherol (Vitamin E). *Organic Ingredients Other Information Protect the product in this container from excessive heat and direct sun
Instructions for use
Information about safe handling and use of the drug product.Directions Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours 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 AM – 2 PM. wear long-sleeved shirts, pants, hats and sunglasses. Use a water resistant sunscreen if swimming or sweating Children under 6 months. Ask a doctor
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 the reach of children. If ingested, consult a Poison Control Center Immediately.
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
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Call 1.917.701.0644
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 o n 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
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