Other
Drug Facts
DIST. BY/PAR: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7
LONDON W1K 3BQ / MM2Y
Mineralize
FDA Label NDC 40046-0061
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Makeup Art Cosmetics for the product Mineralize (NDC 40046-0061). 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 other, otc - purpose, use, 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
| Active Ingredients | Purpose |
|---|---|
| Octinoxate 7.50% | Sunscreen |
| Titanium Dioxide 2.00% | Sunscreen |
Use
helps prevent sunburn
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 product is swallowed, get medical help or contact a Poison Control Center right away.
Directions
For sunscreen use:
- apply liberally 15 minutes before sun exposure
- reapply every two 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-sleeved shirts, pants, hats and sunglasses
- children under 6 months of age: ask a doctor
Inactive Ingredients
water\aqua\eau, peg-30 dipolyhydroxystearate, dimethicone, ethylhexyl palmitate, caprylic/capric triglyceride, neopentyl glycol diethylhexanoate, triethylhexanoin, butylene glycol, glycerin, octyldodecyl neopentanoate, squalane, silica, tocopherol, tocopheryl acetate, sodium hyaluronate, lysine, butyrospermum parkii (shea butter), haberlea rhodopensis leaf extract, tamarindus indica seed extract, beta vulgaris (beet) root extract\beta vulgaris\extrait de racine de betterave, yeast extract\faex\extrait de levure, phytantriol, octyldodecyl pca, sodium pca, trehalose, magnesium chloride, sodium chloride, potassium chloride, zinc chloride, simethicone, synthetic fluorphlogopite, disteardimonium hectorite, polyglyceryl-3 beeswax, triethoxycaprylylsilane, dimethicone crosspolymer-3, tin oxide, urea, triacetin, polyquaternium-51, caprylyl glycol, hexylene glycol, hydrogenated lecithin, disodium edta, phenoxyethanol, sodium dehydroacetate [+/- mica, titanium dioxide (ci 77891), iron oxides (ci 77491), iron oxides (ci 77492), iron oxides (ci 77499)] <iln 39648>
Other Information
protect the product in this container from excessive heat and direct sun
Principal Display Panel - 30 Ml Bottle Carton
M•A•C
MINERALIZE
MOISTURE SPF 15
FOUNDATION
BROAD SPECTRUM SPF 15
30 ML/1.0 US FL OZ e
Principal Display Panel (30 ML Bottle Carton)
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