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Product NDC Code | 52311-686 | ||||
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Drug Name | Nena mineral sunscreen spf 30 |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | CREAM | ||||
Application Number | M020 | ||||
Labeler Name | Ironwood Clay Company Inc. | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Drug Facts Active ingredients (in each dosage unit) Purpose Titanium dioxide 2.3% ……………………………………………………………………… Sunscreen Zinc oxide 22% .…………………….………………………………………………………. 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.Dosage: Cream Route of adminstration: Topical
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients: Aloe Barbadensis Leaf Extract Aloe Barbadensis Leaf Juice Alumina Arachidyl Alcohol Arachidyl Glucoside Behenyl Alcohol Benzyl Alcohol Brassica Campestris/Aleurites Fordi Oil Copolymer Calendula Officinalis Flower Extract Camellia Sinensis Leaf Extract Caprylic/Capric Triglyceride Chromium Oxide Greens Glycerin Glyceryl Stearate SE Helianthus Annuus (Sunflower) Seed Oil Jojoba Esters Myristyl Alcohol Myristyl Glucoside Propanediol Salicylic Acid Sea Silt Sea Silt Extract Sorbic Acid Stearyl Alcohol, Tocopherols Tridecane Undecane Xanthan Gum
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.See "Uses" and "Warnings"
Purpose
Information about the drug product’s indications for use.Uses Helps prevent sunburn. Helps protect from sunburn. If used as directed with other sun protection measures [see Directions (for Use)], decreases the risk of skin cancer and early skin aging caused by the sun. Sun Protection Factor 30 / SPF 30.
Spl product data elements
Usually a list of ingredients in a drug product.NENA Mineral Sunscreen SPF 30 TITANIUM DIOXIDE, ZINC OXIDE ALUMINUM OXIDE ALOE VERA LEAF MEDIUM-CHAIN TRIGLYCERIDES HYDROGENATED JOJOBA OIL CALENDULA OFFICINALIS FLOWER GREEN TEA LEAF TOCOPHEROL MYRISTYL GLUCOSIDE SALICYLIC ACID TITANIUM DIOXIDE TITANIUM DIOXIDE PROPANEDIOL STEARYL ALCOHOL UNDECANE XANTHAN GUM BENZYL ALCOHOL SORBIC ACID ARACHIDYL GLUCOSIDE GLYCERIN MYRISTYL ALCOHOL ARACHIDYL ALCOHOL GLYCERYL STEARATE SE TRIDECANE ZINC OXIDE ZINC OXIDE SUNFLOWER OIL CHROMIC OXIDE BRASSICA RAPA SUBSP. OLEIFERA WHOLE
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.NENA Mineral Sunscreen SPF 30
Instructions for use
Information about safe handling and use of the drug product.Directions Apply liberally and evenly 15 minutes before sun exposure. 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. Use a water resistant sunscreen if swimming or sweating.
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.Refer to "Keep out of reach of children" in "Warnings" section
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? Email [email protected]
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, call a poison control centre or get medical help 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