FDA.reportPublic FDA data

MAC PREP AND PRIME FACE PROTECT LOTION BROAD SPECTRUM SPF 50

Manufacturer
MAKEUP ART COSMETICS | Estee Lauder Companies Inc. | The Estee Lauder Inc
Effective date
2024-12-25
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:48:47

Label at a glance#

ProductMAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 50
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure9 sections

Dosage and administration

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,...

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active IngredientsPurpose
Avobenzone 3.00%Sunscreen
Homosalate 5.00%Sunscreen
Octisalate 5.00%Sunscreen
Octocrylene 2.70%Sunscreen
Oxybenzone 3.00%Sunscreen

Use

INDICATIONS & USAGE SECTION

helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

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

STORAGE AND HANDLING SECTION

protect the product in this container from excessive heat and direct sun

SPL UNCLASSIFIED SECTION

DIST. BY: MAKE-UP ART COSMETICS
TORONTO, ONTARIO, CANADA M5V 1R7
LONDON W1K 3BQ / MTX7

PRINCIPAL DISPLAY PANEL - 30 ML Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - 30 ML Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
2dc76302-91c0-4c35-ad78-99adfb049c4bProduct name120200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2bProduct name220180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508
d223c173-c39b-d764-47d4-d671d3088815Product name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40046-0063-12022-08-04C16284748780-1c7ccaba7-127e-fd44-e053-dadaa90aa01bMAC PREP AND PRIME FACE PROTECT LOTION BROAD SPECTRUM SPF 50
40046-0063-12022-07-29C16284748780-1c7ccaba7-127e-fd44-e053-dadaa90aa01bMAC PREP AND PRIME FACE PROTECT LOTION BROAD SPECTRUM SPF 50
40046-0063-12021-07-26C16284748780-1c7ccaba7-127e-fd44-e053-dadaa90aa01bMAC PREP AND PRIME FACE PROTECT LOTION BROAD SPECTRUM SPF 50
40046-0063-12021-07-23C16284748780-1c7ccaba7-127e-fd44-e053-dadaa90aa01bMAC PREP AND PRIME FACE PROTECT LOTION BROAD SPECTRUM SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40046-0063-1MAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 501 in 1 CARTONLOTION18
40046-0063-1MAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 5030 mL in 1 TUBELOTION308

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40046-0063MAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 50 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [MAKEUP ART COSMETICS]8Current NDC, Legacy NDC, 2 package rows20241227_c26ef380-1309-4a41-862f-eb319d38673d.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 37 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
40046-006340046-0063-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 35 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
METHYL TRIMETHICONES73ZQI0GXMIACT
NEOPENTYL GLYCOL DIHEPTANOATE5LKW3C543XIACT
KUKUI NUT OILTP11QR7B8RIACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
PEG-100 STEARATEYD01N1999RIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
DIPENTAERYTHRITYL TRI-POLYHYDROXYSTEARATED21K655H52IACT
HYALURONATE SODIUMYSE9PPT4THIACT
CAFFEINE3G6A5W338EIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
SORBITOL506T60A25RIACT
METHYL DIHYDROJASMONATE (SYNTHETIC)3GW44CIE3YIACT
ERGOTHIONEINEBDZ3DQM98WIACT
DEHYDROXANTHAN GUM63ZP7I1BQOIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
STEARIC ACID4ELV7Z65APIACT
CETYL ALCOHOL936JST6JCNIACT
LINALOOL, (+/-)-D81QY6I88EIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SODIUM DEHYDROACETATE8W46YN971GIACT
MICAV8A1AW0880IACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAC PREP AND PRIME FACE PROTECT BROAD SPECTRUM SPF 50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONEMAKEUP ART COSMETICSc26ef380-1309-4a41-862f-eb319d38673d2024-12-25WarningsExact identifier
ndc (package): 40046-0063-1
ndc (product): 40046-0063
ndc11 (package): 40046006301
spl id: 2a15b983-41fb-edf5-e063-6394a90a0315
spl set id: c26ef380-1309-4a41-862f-eb319d38673d

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.