Other
Drug Facts
DIST. BY: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7
LONDON W1K 3BQ / MTX7
Mac Prep And Prime Face Protect Broad Spectrum Spf 50 Lotion
FDA Label NDC 40046-0063
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 Mac Prep And Prime Face Protect Broad Spectrum Spf 50 (NDC 40046-0063). 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 |
|---|---|
| Avobenzone 3.00% | Sunscreen |
| Homosalate 5.00% | Sunscreen |
| Octisalate 5.00% | Sunscreen |
| Octocrylene 2.70% | Sunscreen |
| Oxybenzone 3.00% | 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, butyloctyl salicylate, methyl trimethicone, neopentyl glycol diheptanoate, aleurites moluccana (kukui) seed oil, lauryl peg-9 polydimethylsiloxyethyl dimethicone, peg-100 stearate, butylene glycol, glyceryl stearate, dipentaerythrityl tri-polyhydroxystearate, sodium hyaluronate, lavandula angustifolia (lavender) flower water, laminaria ochroleuca extract, laminaria digitata extract, algae extract, caffeine, ethylhexylglycerin, caprylic/capric triglyceride, sorbitol, methyldihydrojasmonate, ergothioneine, dehydroxanthan gum, vp/eicosene copolymer, saccharide isomerate, ammonium acryloyldimethyltaurate/vp copolymer, potassium cetyl phosphate, caprylyl glycol, citric acid, stearic acid, cetyl alcohol, linalool, limonene, disodium edta, phenoxyethanol, sodium dehydroacetate, mica <iln40739>
Other Information
protect the product in this container from excessive heat and direct sun
Principal Display Panel - 30 Ml Tube Carton
M•A•C
PREP+PRIME
FACE PROTECT
LOTION SPF 50
BROAD SPECTRUM
SPF 50
30 ML/1.0 US FL OZ e
Principal Display Panel (30 ML Tube Carton)
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