Active Ingredients
Titanium Dioxide 3.50%
Zinc Oxide 3.50%
Era Organics Mineral Based Spf 15
FDA Label NDC 72400-752
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Era Organics, Inc. for the product Era Organics Mineral Based Spf 15 (NDC 72400-752). 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 active ingredients, purpose, uses:, warnings:, do not use, when using this product, stop use and consult physician, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Sunscreen
Uses:
Helps prevent sunburn.
If used as directed with other sun protection measure (see directions), decreases the 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 Consult Physician
if irritation or rash develops.
Keep Out Of Reach Of Children.
If product is swallowed, get medical attention or contact poison control center immediately
Directions:
Apply liberally 15-minutes before sun exposure.
REAPPLY: At least every two hours.
- Immediately after swimming, sweating or towel drying.
SUN PROTECTION MEASURES: Spending time in the sun increases your risk of skin cancer and early skin aging. to decrease this risk, regularly use sunscreen with broad spectrum protection and an SPF rating of 15 or higher, along with other sun protection measures including:
- Limit time in the sun, especially between 10am and 2pm.
- Wear long sleeve shirts, pants, hats and sunglasses.
- For children under 6-months, consult a physician.
Other Ingredients:
Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua, Camellia Sinensis (Green Tea) Extract, Ethylhexylglycerin, Glycerin, Helianthus Annuus (Sunflower) Oil, Lecithin, Octyl Palmitate, Phenoxyethanol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Sesamum Indicum (Sesame) Seed Oil, Sodium Laurylglucosides Hydroxypropylsulfonate, Theobroma Cacao (Cocoa) Butter, Tocopherol (Vitamin E), Xanthan Gum.
Package Labeling:
Label (Label)
Bottle (Bottle)
Apple (Apple)
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