MOISTURE SURGE SHEERTINT HYDRATOR BROAD SPECTRUM SPF 25

Product NDC
49527-074
11-digit product format
495270074
Labeler code
49527
Product ID
49527-074_079c68e7-7fd2-9bb9-e063-6394a90a5f8e
Type
HUMAN OTC DRUG
Nonproprietary name
OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, and ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
CLINIQUE LABORATORIES LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-16
Substance
OCTINOXATE; OCTISALATE; TITANIUM DIOXIDE; ZINC OXIDE
Active strength
75; 45; 38; 36 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage49527-07449527-074-02DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 27 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage49527-074-02DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage49527-074-02DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage49527-074-02DDiscontinued by firmexcluded / ndc_excluded.zip2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage49527-074-02DDiscontinued by firmexcluded / ndc_excluded.zipa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage49527-074-02DDiscontinued by firmexcluded / ndc_excluded.zipcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage49527-074-02DDiscontinued by firmexcluded / ndc_excluded.zipcdf11ea48f46…ba0047e9e063…
2025-02-27 05:24 UTC · source 2025-02-26unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipf268b84574a6…26285f5ac5df…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage49527-074-02DDiscontinued by firmexcluded / ndc_excluded.zip302b2466d912…e7b80fea0513…
2025-02-01 13:13 UTC · source 2025-01-31unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipf764e8902f78…92046438deef…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49527-074-02DDiscontinued by firmexcluded / ndc_excluded.ziped331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-17unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip68b1e3bced9e…98a755eb8bc6…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49527-074-02DDiscontinued by firmexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2024-11-29 20:42 UTC · source 2024-11-29unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip05c55d027831…ca05dca9dc4c…
2024-11-29 20:42 UTC · source 2024-11-29unfinished packagepackage49527-074-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip05c55d027831…ca05dca9dc4c…
2024-11-09 02:36 UTC · source 2024-11-08unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:36 UTC · source 2024-11-08unfinished packagepackage49527-074-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip48b4f40e6753…c7c7a00d2afa…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage49527-074-02DDiscontinued by firmexcluded / ndc_excluded.zipad56d346431e…cc804d4bbf1e…
2024-10-09 02:27 UTC · source 2024-10-08unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip27f29a85d7e4…1372111e901f…
2024-10-09 02:27 UTC · source 2024-10-08unfinished packagepackage49527-074-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip27f29a85d7e4…1372111e901f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage49527-074-02DDiscontinued by firmexcluded / ndc_excluded.zip367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09unfinished packagepackage49527-074-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip8d62ce987f31…9fe9ef23e30d…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage49527-074-02DDiscontinued by firmexcluded / ndc_excluded.zip557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:11 UTC · source 2024-05-28unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipd1e113ab4d42…063ee3eb0a1d…
2024-05-28 21:11 UTC · source 2024-05-28unfinished packagepackage49527-074-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zipd1e113ab4d42…063ee3eb0a1d…
2024-05-15 03:51 UTC · source 2024-05-14unfinished productproductUNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip50b4072663b7…eae3003ed65e…
2024-05-15 03:51 UTC · source 2024-05-14unfinished packagepackage49527-074-00UNFINISHEDActive or certified unfinished drug listingunfinished / ndc_unfinished.zip50b4072663b7…eae3003ed65e…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
MOISTURE SURGE SHEERTINT HYDRATOR BROAD SPECTRUM SPF 25
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE75 mg/mL
OCTISALATE45 mg/mL
TITANIUM DIOXIDE38 mg/mL
ZINC OXIDE36 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4Y5P7MUD51Internal UNII lookup
4X49Y0596WInternal UNII lookup
15FIX9V2JPInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
159410d4-4479-4442-b371-bde72aae3e1eAvailable on FDA.report

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49527-074-01MOISTURE SURGE SHEERTINT HYDRATOR BROAD SPECTRUM SPF 2540 mL in 1 TUBECREAM407
49527-074-01MOISTURE SURGE SHEERTINT HYDRATOR BROAD SPECTRUM SPF 251 in 1 CARTONCREAM17
49527-074-02MOISTURE SURGE SHEERTINT HYDRATOR BROAD SPECTRUM SPF 251 mL in 1 TUBECREAM17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49527-074MOISTURE SURGE SHEERTINT HYDRATOR BROAD SPECTRUM SPF 25 (OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDE) CREAM [CLINIQUE LABORATORIES LLC]7Current NDC, Legacy NDC, 3 package rows20231019_159410d4-4479-4442-b371-bde72aae3e1e.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 5 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HAWAIIAN TROPICAVOBENZONE, HOMOSALATE, OCTOCRYLENEEdgewell Personal Care Brands LLC5990fe66-4fa2-06aa-e063-6294a90a52612026-08-21WarningsExact identifier
application number: M020
Hawaiian TropicAVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENEEdgewell Personal Care Brands LLC5991466a-e729-16b7-e063-6394a90a11ff2026-08-21WarningsExact identifier
application number: M020
Avobenzone, Homosalate, OctisalateAVOBENZONE, HOMOSALATE, OCTISALATETopco Associates LLC597b78df-83cb-1b21-e063-6294a90a56a82026-08-20Warnings, Adverse reactionsExact identifier
application number: M020
Sunski Base Camp Face and Body Sunscreen SPF 45HOMOSALATE, OCTISALATE, AVOBENZONEStewart Charley Ventures, LLC2fc45f85-a6f8-4893-8b34-4db5e39cb6152026-08-20WarningsExact identifier
application number: M020
Sweat Resistant Sunscreen Body OriginalTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc.4bbde755-e312-123e-e063-6294a90a467f2026-08-20WarningsExact identifier
application number: M020
SunscreenBROAD SPECTRUM SPF 30Concierge Choice LLC5980055b-493e-4763-e063-6294a90a570f2026-08-20WarningsExact identifier
application number: M020
Lip Balm SPF 15AVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENESkin Script, LLC20c5fde7-ee8f-4b74-e063-6394a90a93ec2026-08-19WarningsExact identifier
application number: M020
Aloe UP .5OZ SPF 50 MINERAL SunscreenZINC OXIDE 14.69%Aloe Care International, LLC6ad80af3-78cd-4211-a5f2-68531aae264a2026-08-19WarningsExact identifier
application number: M020
Utu Broad Spectrum SPF 50 Tinted Sunscreen-StickZINC OXIDEUtu Co596e17d3-3064-1cda-e063-6294a90af9632026-08-19WarningsExact identifier
application number: M020
Mineral sunscreenMINERAL SUNSCREENGuangzhou Origin Beauty Cosmetics Co., Ltd.59713657-a7ef-1aee-e063-6394a90a326e2026-08-19WarningsExact identifier
application number: M020
The Naked Bee SPF 50 Mineral SunscreenZINC OXIDE 14.69%The Naked Beef820a9be-c94d-4fd5-b202-2dda5746a82a2026-08-18WarningsExact identifier
application number: M020
The Naked Bee SPF 50 Mineral SunscreenZINC OXIDE 20%The Naked Bee7dd2b1cd-e229-4eeb-8122-46fde5af10912026-08-18WarningsExact identifier
application number: M020
Sun Zapper - Baby pure zinc sunscreen SPF30ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED3ee52faa-64a8-4bdf-e063-6294a90a65cf2026-08-17WarningsExact identifier
application number: M020
Sun Zapper - Face pure zinc sunscreen SPF30ZINC OXIDE SUNSCREENVEGANIC SKN LIMITED3ee4feb3-6966-67f9-e063-6394a90a16d52026-08-17WarningsExact identifier
application number: M020
HEADHUNTER SURF SCREEN SPF 50 SUNSCREENZINC OXIDE,TITANIUM DIOXIDEGuangzhou Tata Biotechnology Co., Ltd.4339df13-77d3-31a1-e063-6394a90a52082026-08-17WarningsExact identifier
application number: M020
Soleil Defense SunscreenBROAD SPECTRUM SPF 30AMARA MED SPA LLC594244b1-db3b-002b-e063-6394a90a03292026-08-17WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30HAMBLIN DERMATOLOGY5942e64c-416e-7525-e063-6394a90a28392026-08-17WarningsExact identifier
application number: M020
Protect Tinted Mineral SunscreenBROAD SPECTRUM SPF30Opal Day Spa5943413a-48e1-0bdf-e063-6294a90a2fff2026-08-17WarningsExact identifier
application number: M020
Stay Ageless Tinted Mineral SunscreenBROAD SPECTRUM SPF30MedSpa By Beauty Bar LLC5943ba3d-688e-9e9c-e063-6294a90afa9a2026-08-17WarningsExact identifier
application number: M020
SunscreenBROAD SPECTRUM SPF 30Charleston Dermatology, P.C.59440f7f-4213-6e2b-e063-6394a90af4832026-08-17WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49527-074-01495270074011 TUBE in 1 CARTON (49527-074-01) / 40 mL in 1 TUBE1 tube2019-10-160000-00-00NoNoCurrent
49527-074-02495270074021 mL in 1 TUBE (49527-074-02) 1 ml2019-10-160000-00-00NoNoCurrent