Tinted Mineral Sunscreen Broad Spectrum Spf 40 Lotion
FDA Label NDC 72812-153
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Earth Mama Angel Baby, Llc for the product Tinted Mineral Sunscreen Broad Spectrum Spf 40 (NDC 72812-153). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient
Zinc Oxide 25%
Purpose
Sunscreen
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.
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
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If product is swallowed, get medical help or contact Poison Control Center right away.
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
Other Information
• Protect the product in this container from excessive heat and direct sun.
Inactive Ingredients
Caprylic/Caprylic Triglyceride*, Cocos Nucifera (Coconut) Oil*, Olea Europaea (Olive) Fruit Oil*, Beeswax*, Rubus Idaeus (Raspberry) Seed Oil*, Punica Granatum Seed Oil*, Simmondsia Chinensis (Jojoba) Oil*, Butyrospermum Parkii (Shea) Butter*, Tocopherol, Argania Spinosa Kernel Oil*, Calendula Officinalis Flower Extract*, Iron Oxide, Mica
*Organic
Questions Or Comments?
503-607-0607 or earthmamaorganics.com
Packaging
Image Description (72812153 1)
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