FDA.reportPublic FDA data

PREP (plus) PRIME BEAUTY BALM

Manufacturer
MAKE-UP ART COSMETICS | ESTEE LAUDER COSMETICS, LTD | ESTEE LAUDER N.V. | Len-Ron Manufacturing Division of Aramis Inc. | Aramis Inc. | Northtec Bristol | Northtec Keystone | PADC 1 | Estee Lauder Pennsylvania Distribution Center 2 | Estee Lauder Cosmetics, Ltd. | Estee Lauder Cosmetics Distribution Center | Estee Lauder Kabushiki Kaisha | Whitman Laboratories Ltd.
Effective date
2010-05-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:25:16

Label at a glance#

ProductPREP (plus) PRIME BEAUTY BALM SPF 35
Active ingredientOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE
Label structure4 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS: OCTINOXATE 7.40% [] OCTISALATE 4.00% [] OXYBENZONE 2.50% [] TITANIUM DIOXIDE 1.10% [] ZINC OXIDE 3.50%

OTC - WHEN USING SECTION

DIRECTIONS:SMOOTH EVENLY ALL OVER THE FACE OR TO THE DESIRED AREA AFTER MOISTURIZER WITH FINGERTIPS, SPONGE OR BRUSH

WARNINGS SECTION

WARNING: KEEP OUT OF EYES. STOP USE IF IRRITATION OCCURS. KEEP OUT OF REACH OF CHILDREN.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL:

MAC

PREP + PRIME

BB

BEAUTY BALM

SPF 35


30 ML/1.0 US FL OZ


DIST. BY MAKEUP ART COSMETICS

TORONTO, ONTARIO CANADA M5V 1R7

MAC COSMETICS.COM

FOLDING CARTON
FOLDING CARTON

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
40046-0036-12020-01-31C16284748780-19d75b9d0-5d2e-f424-e053-dadaa90a57ce390daee0-d16b-466a-81df-c30d130f833d

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
40046-0036-1PREP (plus) PRIME BEAUTY BALMSPF 351 in 1 CARTONCREAM11
40046-0036-2PREP (plus) PRIME BEAUTY BALMSPF 3530 mL in 1 TUBECREAM301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
40046-0036PREP (PLUS) PRIME BEAUTY BALM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MAKE-UP ART COSMETICS]1Legacy NDC, 2 package rows20100720_390daee0-d16b-466a-81df-c30d130f833d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OCTISALATEACTIVE INGREDIENT4X49Y0596W1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
ZINC OXIDEACTIVE MOIETYSOI2LOH54Z1

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
40046-003640046-0036-2, 40046-0036-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

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
e9ac9caf-34b9-4218-ae0a-fa2182c2898f390daee0-d16b-466a-81df-c30d130f833d2010-05-14WarningsExact identifier
spl id: e9ac9caf-34b9-4218-ae0a-fa2182c2898f
spl set id: 390daee0-d16b-466a-81df-c30d130f833d

Reported adverse events (FAERS/openFDA)#

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