La Roche Posay Laboratoire Dermatologique Hydraphase UV Intense Moisturizer Broad Spectrum SPF 20 Sunscreen

Product NDC
49967-126
11-digit product format
499670126
Labeler code
49967
Product ID
49967-126_4a222f05-8c59-4f1d-b10b-497925401248
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Homosalate, Octisalate and Octocrylene
Dosage form
LOTION
Route
TOPICAL
Labeler
L'Oreal USA Products Inc
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2012-09-01
Substance
AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength
30; 47; 50; 70 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 packagepackage49967-12649967-126-01DDiscontinued by firm2026-10-21

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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
La Roche Posay Laboratoire Dermatologique Hydraphase UV Intense Moisturizer Broad Spectrum SPF 20 Sunscreen
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
AVOBENZONE30 mg/mL
HOMOSALATE47 mg/mL
OCTISALATE50 mg/mL
OCTOCRYLENE70 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G63QQF2NOXInternal UNII lookup
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
5A68WGF6WMInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ad4f45b2-3391-4e32-9744-28838727260cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49967-126-01La Roche Posay Laboratoire Dermatologique Hydraphase UV Intense Moisturizer Broad Spectrum SPF 20 Sunscreen1 in 1 CARTONLOTION14
49967-126-01La Roche Posay Laboratoire Dermatologique Hydraphase UV Intense Moisturizer Broad Spectrum SPF 20 Sunscreen50 mL in 1 TUBELOTION504
49967-126-02La Roche Posay Laboratoire Dermatologique Hydraphase UV Intense Moisturizer Broad Spectrum SPF 20 Sunscreen1 in 1 CARTONLOTION14
49967-126-02La Roche Posay Laboratoire Dermatologique Hydraphase UV Intense Moisturizer Broad Spectrum SPF 20 Sunscreen50 mL in 1 BOTTLELOTION504

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOXLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE HYDRAPHASE UV INTENSE MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]1
HOMOSALATEACTIVE INGREDIENTV06SV4M95SLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE HYDRAPHASE UV INTENSE MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]1
OCTISALATEACTIVE INGREDIENT4X49Y0596WLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE HYDRAPHASE UV INTENSE MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]1
OCTOCRYLENEACTIVE INGREDIENT5A68WGF6WMLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE HYDRAPHASE UV INTENSE MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]1
AVOBENZONEACTIVE MOIETYG63QQF2NOXLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE HYDRAPHASE UV INTENSE MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]1
HOMOSALATEACTIVE MOIETYV06SV4M95SLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE HYDRAPHASE UV INTENSE MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]1
OCTISALATEACTIVE MOIETY4X49Y0596WLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE HYDRAPHASE UV INTENSE MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]1
OCTOCRYLENEACTIVE MOIETY5A68WGF6WMLA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE HYDRAPHASE UV INTENSE MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49967-126LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE HYDRAPHASE UV INTENSE MOISTURIZER BROAD SPECTRUM SPF 20 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L'OREAL USA PRODUCTS INC]4Current NDC, Legacy NDC, 4 package rows20240102_ad4f45b2-3391-4e32-9744-28838727260c.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
49967-126-01499670126011 TUBE in 1 CARTON (49967-126-01) > 50 mL in 1 TUBE1 tube2012-09-010000-00-00NoNoCurrent
49967-126-02499670126021 BOTTLE in 1 CARTON (49967-126-02) / 50 mL in 1 BOTTLE1 bottle2012-09-010000-00-00NoNoCurrent