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Product NDC Code | 72812-149 | ||||
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Drug Name | Earth mama lady face mineral sunscreen - light/medium tint broad spectrum spf 40 |
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Type | Brand | ||||
Pharm Class | Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE] |
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Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | STICK | ||||
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 22%
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 • 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*, Helianthus Annuus (Sunflower) Seed Oil*, Beeswax*, Euphorbia Cerifera (Candelilla) Wax, Copernicia Cerifera (Carnauba) Wax*, Butyrospermum Parkii (Shea) Butter*, Tocopherol, Theobroma Cacao (Cocoa) Seed Butter*, Aloe Barbadensis (Aloe Vera) Leaf Juice*, Calendula Officinalis (Calendula) Flower Extract*, Titanium Dioxide, Iron Oxides. *Organic
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.
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 Lady Face Mineral Sunscreen - Light/Medium Tint Broad Spectrum SPF 40 Zinc Oxide ZINC OXIDE ZINC CATION COCONUT OIL SUNFLOWER OIL YELLOW WAX CANDELILLA WAX CARNAUBA WAX SHEA BUTTER TOCOPHEROL COCOA BUTTER ALOE VERA LEAF CALENDULA OFFICINALIS FLOWER TITANIUM DIOXIDE FERRIC OXIDE RED
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 Light/Medium Tint
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
MOISTURIZING TINTED FACE STICK Water Resistant (40 Minutes) NSF contains organic ingredients PLASTIC NEUTRAL FOR EVERYONE AND THEIR MOTHER. ® Hello, Sunshine! This broad-spectrum mineral sunscreen stick is formulated to protect your skin without concerning chemicals - and contains moisturizing organic shea and cocoa butter, plus powerful, ray-scattering non-nano zinc. It's tinted with sheer color that blends like a dream and blocks blue light from digital screens. Because we think skin protection can be simple, and we went you to be safely sun-kissed. Always. Moisturizing Mineral Sun Protection UVA/UVB Protection DERMATOLOGIST TESTED AND CLINICALLY TESTED FOR IRRITATION NON-NANO ZINC REEF-FRIENDLY NO OXYBENZONE, OCTINOXATE OR AVOBENZONE NO PARABENS, ARTIFICIAL FRAGRANCE OR PRESERVATIVES Retain this carton for full Drug Facts information. Distributed by Earth Mama Angel Baby ® LLC 9866 SE Empire Ct. • Clackamas, OR 97015 USA Certified to NSF/ANSI 305 by Oregon Tilth Leaping Bunny Certified Grounded in Nature, Powered by Love. ®
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
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 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