FDA.reportPublic FDA data

DAYWEAR MULTI-PROTECTION ANTII-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN

Product NDC
11559-049
11-digit product format
115590049
Labeler code
11559
Product ID
11559-049_f0ffee4b-017a-964e-e053-2995a90a2b63
Type
HUMAN OTC DRUG
Nonproprietary name
AVOBENZONE and OCTISALATE
Dosage form
CREAM
Route
TOPICAL
Labeler
ESTEE LAUDER INC
Application
M020
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-12-01
Marketing end
0000-00-00
Substance
AVOBENZONE; OCTISALATE
Active strength
30 mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11559-049IInactivated by FDA2026-10-21
excluded packagepackage11559-04911559-049-01IInactivated by FDA2026-10-21
excluded packagepackage11559-04911559-049-02IInactivated by FDA2026-10-21
excluded packagepackage11559-04911559-049-03IInactivated by FDA2026-10-21
excluded packagepackage11559-04911559-049-04IInactivated by FDA2026-10-21

Reported adverse events (FAERS/openFDA)#

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

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#

Effective, Related label table
EffectiveRelated label
2022-08-05DAYWEAR MULTI-PROTECTION ANTI-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN
2022-08-05DAYWEAR MULTI-PROTECTION ANTI-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN
2022-07-29DAYWEAR MULTI-PROTECTION ANTI-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN
2022-07-29DAYWEAR MULTI-PROTECTION ANTI-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN
2021-07-26DAYWEAR MULTI-PROTECTION ANTI-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN
2021-07-26DAYWEAR MULTI-PROTECTION ANTI-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN
2021-07-23DAYWEAR MULTI-PROTECTION ANTI-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN
2021-07-23DAYWEAR MULTI-PROTECTION ANTI-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11559-049-01DAYWEAR MULTI-PROTECTION ANTII-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN50 mL in 1 JARCREAM5013
11559-049-01DAYWEAR MULTI-PROTECTION ANTII-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN1 in 1 CARTONCREAM113
11559-049-02DAYWEAR MULTI-PROTECTION ANTII-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN1 in 1 CARTONCREAM113
11559-049-02DAYWEAR MULTI-PROTECTION ANTII-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN15 mL in 1 JARCREAM1513
11559-049-03DAYWEAR MULTI-PROTECTION ANTII-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN30 mL in 1 JARCREAM3013
11559-049-04DAYWEAR MULTI-PROTECTION ANTII-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN7 mL in 1 JARCREAM713

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11559-049DAYWEAR MULTI-PROTECTION ANTII-OXIDANT 24H-MOISTURE CREME BROAD SPECTRUM SPF 15 NORMAL/COMBINATION SKIN (AVOBENZONE AND OCTISALATE) CREAM [ESTEE LAUDER INC]13Legacy NDC, 6 package rows20250410_46fa88a3-b187-41da-9373-005182ec1083.zip

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 64 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sport Sunscreen SPF 70AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC6d1ad14e-afc6-4676-87d7-3e50e3a02fe92026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Sunscreen for Babies SPF 50AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC64766ed9-bd47-498d-bf59-fb30a7bf7e892026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Broad Spectrum Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLCccb651f6-e567-4c5f-9109-8767270cc4be2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenAVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLC80dcd255-3a6c-4b79-b081-519c9dac990a2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Moisturizing Sunscreen SPF 50AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Service, LLC9de8b6b1-024b-4b71-96e6-fea68088d3ab2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
SunscreenSUNSCREENRetail Business Services, LLC96221c10-ebfe-4385-b6b5-d504258df36c2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
Moisturizing Sunscreen SPF 30AVOBENZONE, HOMOSALATE, OCTISALATERetail Business Services, LLCe2adbde9-3c8b-45f3-b4ef-4936b88d812d2026-02-06Warnings, Adverse reactionsExact identifier
application number: M020
NUDESCREEN DEWY ILLUMINATING GLOW SPF 30 - Sunkissed GlowZINC OXIDE SUNSCREENBentley Laboratories, LLCbf1a237b-b27e-4c55-8ded-e348240a5b9a2026-02-06WarningsExact identifier
application number: M020
SEYTU Body SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.c411e9a6-b2ea-446b-a886-b92c61736e6c2026-02-05WarningsExact identifier
application number: M020
SEYTU Facial SunscreenTITANIUM DIOXIDE AND ZINC OXIDEOmnilife USA, Inc.96fd37fb-c3ff-413f-b2c8-50754f320ecc2026-02-05WarningsExact identifier
application number: M020
Sun Veil IlluminatingElixir Face Sunscreen SPF 38OCTISALATE, OCTOCRYLENE, ZINC OXIDEKoco Life LLC4a15c479-d676-9e52-e063-6394a90a4eb42026-02-05WarningsExact identifier
application number: M020
Golden Sunglaze Sheer Body Mist Sunscreen SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKoco Life LLC22d0a5db-6af1-a3ca-e063-6394a90a68ef2026-02-05WarningsExact identifier
application number: M020
Sunglaze Sheer Setting Mist Sunscreen SPF50AVOBENZONE, HOMOSALATE, OCTISALATE, OCTYOCRYLENEKoco Life LLC22ce9b26-2bf8-c1ea-e063-6394a90a8ec22026-02-05WarningsExact identifier
application number: M020
Peppermint SPF 15 Sunscreen Lip BalmAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENENaples Soap Company, Inc.24adffd4-5177-f5d5-e063-6294a90a78502026-02-05WarningsExact identifier
application number: M020
No7 Restore and Renew Multi Action Serum Foundation Sunscreen Broad Spectrum SPF 20 BambooOCTINOXATE, TITANIUM DIOXIDEBCM Cosmetique SASebfe03e7-614f-44b1-b1f1-78edc7e274cc2026-02-05WarningsExact identifier
application number: M020
Serious Skincare Serious-C3 Plasma Bio Technology C Cream SPF 30AVOBENZONE, OCTOCRYLENE, OCTINOXATE, OCTISALATE, OXYBENZONEFlageoli Limited66f29201-6cbe-46d0-b54c-005a1ecefac42026-02-04WarningsExact identifier
application number: M020
Tanning Club Mineral Sunscreen SPF 30ZINC OXIDETanning Club LLCd674ccbc-7bae-435c-a531-a79e569e69a92026-02-04WarningsExact identifier
application number: M020
Derma B Everyday Fit Sunscreen SPF 50AVOBEZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENENeoPharm Co., Ltd.ba38a43d-7a8a-4814-ba34-0e99124f5fca2026-02-04WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT oil-free MINERAL SUNSCREEN SPF 42TITANIUM DIOXIDE AND ZINC OXIDESHISEIDO AMERICAS CORPORATION86630e82-f249-4866-82dd-3e21feb266c42026-02-04WarningsExact identifier
application number: M020
SHISEIDO URBAN ENVIRONMENT FRESH-MOISTURE SUNSCREEN SPF 42AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENESHISEIDO AMERICAS CORPORATION42adc51f-f500-485d-82a0-1266721412622026-02-04WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11559-049-01115590049011 JAR in 1 CARTON (11559-049-01) > 50 mL in 1 JAR1 jar2017-12-010000-00-00NoNoCurrent
11559-049-02115590049021 JAR in 1 CARTON (11559-049-02) > 15 mL in 1 JAR1 jar2022-12-010000-00-00NoNoCurrent
11559-049-031155900490330 mL in 1 JAR (11559-049-03) 30 ml2022-12-010000-00-00NoNoCurrent
11559-049-04115590049047 mL in 1 JAR7 mlHistorical