FDA.reportPublic FDA data

NDC 40046-0036-2 - PREP (plus) PRIME BEAUTY BALM SPF 35

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
40046-0036
Requested NDC
40046-0036-2
Package NDCs from labels
40046-0036-2, 40046-0036-1
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
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
PREP (plus) PRIME BEAUTY BALM SPF 35MAKE-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.2010-05-14HUMAN OTC DRUG LABEL

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
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD51PREP (PLUS) PRIME BEAUTY BALM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MAKE-UP ART COSMETICS]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WPREP (PLUS) PRIME BEAUTY BALM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MAKE-UP ART COSMETICS]1
OXYBENZONEACTIVE INGREDIENT95OOS7VE0YPREP (PLUS) PRIME BEAUTY BALM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MAKE-UP ART COSMETICS]1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JPPREP (PLUS) PRIME BEAUTY BALM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MAKE-UP ART COSMETICS]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZPREP (PLUS) PRIME BEAUTY BALM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MAKE-UP ART COSMETICS]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51PREP (PLUS) PRIME BEAUTY BALM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MAKE-UP ART COSMETICS]1
OCTISALATEACTIVE MOIETY4X49Y0596WPREP (PLUS) PRIME BEAUTY BALM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MAKE-UP ART COSMETICS]1
OXYBENZONEACTIVE MOIETY95OOS7VE0YPREP (PLUS) PRIME BEAUTY BALM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MAKE-UP ART COSMETICS]1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JPPREP (PLUS) PRIME BEAUTY BALM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MAKE-UP ART COSMETICS]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZPREP (PLUS) PRIME BEAUTY BALM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE) CREAM [MAKE-UP ART COSMETICS]1

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 5 of 373 · 7,452 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Homosalate, Octisalate, Zinc oxideHOMOSALATE, OCTISALATE, ZINC OXIDEAldi Inc59cbfb14-d9b1-ce93-e063-6394a90ac3122026-08-24Warnings, Adverse reactionsExact identifier
unii: SOI2LOH54Z
unii: 4X49Y0596W
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela59cf1d1e-e951-9d58-e063-6394a90af0f32026-08-24WarningsExact identifier
unii: SOI2LOH54Z
SKIN-INFUSED FOUNDATION SPF 25/ Mineral sunscreen broad Spectrum SPF 25 01ZINC OXIDE, TITANIUM DIOXIDECosmuses Cosmetics (Ningbo) Co., Ltd.59d74e3f-e3fa-a7a9-e063-6294a90a76e52026-08-24WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
ISNTREE HYALURONIC ACID WATERY SUNSCREENAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEISNTREE Inc.59ac747a-f9c7-2c18-e063-6394a90a23062026-08-23WarningsExact identifier
unii: 4X49Y0596W
ClaravieZINC OXIDE, DIMETHICONEGentell LLC598a5c0b-1e2f-1335-e063-6394a90ac4f42026-08-21WarningsExact identifier
unii: SOI2LOH54Z
Sunski Sol Power Daily Face Sunscreen SPF 50HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEStewart Charley Ventures, LLCb6c3d6b1-3d8a-43c0-aac5-07fe60afbd8c2026-08-21WarningsExact identifier
unii: 4X49Y0596W
Hawaiian TropicAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC5991466a-e729-16b7-e063-6394a90a11ff2026-08-21WarningsExact identifier
unii: 4X49Y0596W
MUSTELA Diaper Rash 1 2 3ZINC OXIDEExpanscience Laboratories d/b/a Mustela163f388e-849d-4b7e-93c1-9045d77a9ec22026-08-21WarningsExact identifier
unii: SOI2LOH54Z
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP0073de92-585d-e01a-e063-6394a90a2ec22026-08-21WarningsExact identifier
unii: SOI2LOH54Z
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC597b78df-83cb-1b21-e063-6294a90a56a82026-08-20Warnings, Adverse reactionsExact identifier
unii: 4X49Y0596W
Sunski Base Camp Face and Body Sunscreen SPF 45HOMOSALATE, OCTISALATE, AVOBENZONEStewart Charley Ventures, LLC2fc45f85-a6f8-4893-8b34-4db5e39cb6152026-08-20WarningsExact identifier
unii: 4X49Y0596W
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
unii: SOI2LOH54Z
unii: 15FIX9V2JP
SunscreenBROAD SPECTRUM SPF 30Concierge Choice LLC5980055b-493e-4763-e063-6294a90a570f2026-08-20WarningsExact identifier
unii: 4X49Y0596W
ClaraVieZINC OXIDEGentell LLC596abd98-17d7-2a22-e063-6294a90af57d2026-08-19WarningsExact identifier
unii: SOI2LOH54Z
Lip Balm SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENESkin Script, LLC20c5fde7-ee8f-4b74-e063-6394a90a93ec2026-08-19WarningsExact identifier
unii: 4X49Y0596W
unii: 4Y5P7MUD51
ClaraVieMENTHOL, ZINC OXIDEGentell LLC596c467f-a056-ea78-e063-6394a90a79f22026-08-19WarningsExact identifier
unii: SOI2LOH54Z
Aloe UP .5OZ SPF 50 MINERAL SunscreenZINC OXIDE 14.69%Aloe Care International, LLC6ad80af3-78cd-4211-a5f2-68531aae264a2026-08-19WarningsExact identifier
unii: SOI2LOH54Z
Utu Broad Spectrum SPF 50 Tinted Sunscreen-StickZINC OXIDEUtu Co596e17d3-3064-1cda-e063-6294a90af9632026-08-19WarningsExact identifier
unii: SOI2LOH54Z
Mineral sunscreenMINERAL SUNSCREENGuangzhou Origin Beauty Cosmetics Co., Ltd.59713657-a7ef-1aee-e063-6394a90a326e2026-08-19WarningsExact identifier
unii: SOI2LOH54Z
The Naked Bee SPF 50 Mineral SunscreenZINC OXIDE 14.69%The Naked Beef820a9be-c94d-4fd5-b202-2dda5746a82a2026-08-18WarningsExact identifier
unii: SOI2LOH54Z

Reported adverse events (FAERS/openFDA)#

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