Otc - Active Ingredient
Active ingredients
Avobenzone: 2.7%
Homosalate: 9.5%
Octisalate:4.5%
Octocrylene: 5%
Mistine Uv Defense Face Sunscreen Spf50 Cream
FDA Label NDC 87458-005
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Better Invention Ltd for the product Mistine Uv Defense Face Sunscreen Spf50 (NDC 87458-005). 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 otc - active ingredient, otc - purpose, uses, warnings, otc - do not use, otc - when using, otc - stop use, otc - 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
Otc - Purpose
Purpose
Sunscreen
Uses
Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.
Warnings
Warnings
For external use only
Otc - Do Not Use
Do not use on damaged or broken skin.
Otc - When Using
When using this product, keep out of eyes. Rinse with water to remove.
Otc - Stop Use
Stop use and ask a doctor if rash occurs.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Directions
Directions
- apply liberally 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water resistant sunscreen if swimming or sweating
- 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-sleeve shirts, pants, hats, and sunglasses.
- children under 6 months: Ask a doctor
Inactive Ingredient
Inactive ingredients
Octyldodecanol, Butylene Glycol Dicaprylate/Dicaprate, Dibutyl Lauroyl Glutamide, Diisostearyl Malate, Dibutyl Ethylhexanoyl Glutamide, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Dextrin Palmitate, Tocopheryl Acetate, Squalane, Ascorbyl Tetraisopalmitate, Butylene Glycol, Oryza Sativa (Rice) Bran Extract, 1,2-Hexanediol.
Other Information
Other information
- protect the product in this container from excessive heat and direct sun.
Package Label.Principal Display Panel
Tube (Facestick Pp)
Carton (Facestick Sp)
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