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| Product NDC Code | 72812-154 | ||||
|---|---|---|---|---|---|
| Drug Name | Earth mama uber-sensitive mineral sunscreen spf 40 |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION | ||||
| Application Number | M020 | ||||
| Labeler Name | Earth Mama Angel Baby, LLC | ||||
| Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Zinc Oxide 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.Directions • For Eczema: Apply as needed. • Apply generously and evenly to all skin exposed to sun 15 minutes before sun exposure • 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 • Reapply • after 40 minutes of swimming or sweating • immediately after towel drying • at least every 2 hours
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Cocos Nucifera (Coconut) Oil*, Cocos Nucifera (Fractionated Coconut) Oil*, Cera Alba (Beeswax)*, Olea Europaea (Olive) Fruit Oil*, Rubus Idaeus (Red Raspberry) Seed Oil*, Simmondsia Chinensis (Jojoba) Seed Oil*, Butyrospermum Parkii (Shea) Butter*, Oryza Sativa (Rice) Bran Oil*, Tocopherol, Avena Sativa (Oat) Kernel Flour*, Aloe Barbadensis (Aloe Vera) Leaf Juice*, Calendula Officinalis (Calendula) Flower Extract*
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.Uses • Helps prevent sunburn • If used as directed with other sun protection measures ( see Directions ), decreases risk of skin cancer and early skin aging caused by the sun. • Temporarily protects and helps relieve minor skin irritation and itching due to: • rashes • eczema • poison ivy, oak, or sumac • insect bites. • For use on mild to moderate eczema or as directed by a physician.
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.earth mama UBER-SENSITIVE MINERAL Sunscreen SPF 40 Zinc Oxide ZINC OXIDE ZINC OXIDE COCONUT OIL MEDIUM-CHAIN TRIGLYCERIDES YELLOW WAX OLIVE OIL RASPBERRY SEED OIL JOJOBA OIL SHEA BUTTER RICE BRAN OIL TOCOPHEROL OATMEAL ALOE VERA LEAF CALENDULA OFFICINALIS FLOWER
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.Packaging SUNSCREEN LOTION-154
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.Drug Facts
THERAPEUTIC ECZEMA ITCH RELIEF Pediatrician & Dermatologist Tested Water Resistant (40 Minutes) Broad Spectrum UVA/UVB Protection Non-Nano / Reef-Safe Contains Organic Shea Butter & Colloidal Oatmeal NSF contains organic ingredients PLASTIC NEUTRAL NO Oxybenzone, Octinoxate, Artificial Preservatives or Fragrance FOR EVERYONE AND THEIR MOTHER. TM *Organic Distributed by Earth Mama Angel Baby ® LLC 9866 SE Empire Ct. • Clackamas, OR 97015 USA Certified to the NSF/ANSI 305 Standard by Oregon Tilth Awarded the National Eczema Association Seal of Acceptance TM • Leaping Bunny Certified
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 product is swallowed, get medical help or contact 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.Questions or comments? 503-607-0607 or earthmama.com
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. • Store at room temperature.
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. • condition worsens • symptoms last more than 7 days or clear up and occur again within a few days. Keep out of reach of children . If product is swallowed, get medical help or contact 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