Home NDC 49967-584 La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen
Product NDC 49967-584
11-digit product format 499670584
Labeler code 49967
Product ID 49967-584_1e3bc0f0-d0c5-475a-8793-300736f9e6bd
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 2016-12-21
Substance AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE
Active strength 30; 50; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes
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 date Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 367a005e9d99…383a685ebd0f…2024-07-10 04:00 UTC · source 2024-07-09 557ba5c1ecfa…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 Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength AVOBENZONE 30 mg/mL HOMOSALATE 50 mg/mL OCTISALATE 50 mg/mL OCTOCRYLENE 70 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49967-584-01 La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen 75 mL in 1 BOTTLE LOTION 75 14 49967-584-01 La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen 1 in 1 CARTON LOTION 1 14 49967-584-02 La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen 2 mL in 1 PACKET LOTION 2 14 49967-584-03 La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen 3 mL in 1 TUBE LOTION 3 14 49967-584-04 La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen 1 in 1 CARTON LOTION 1 14 49967-584-04 La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen 100 mL in 1 TUBE LOTION 100 14 49967-584-05 La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen 1 in 1 CARTON LOTION 1 14 49967-584-05 La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen 75 mL in 1 TUBE LOTION 75 14 49967-584-06 La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen 1 in 1 CARTON LOTION 1 14 49967-584-06 La Roche Posay Laboratoire Dermatologique Toleriane Double Repair Moisturizer UV Broad Spectrum SPF 30 Sunscreen 40 mL in 1 TUBE LOTION 40 14
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49967-584 LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE TOLERIANE DOUBLE REPAIR MOISTURIZER UV BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [L’OREAL USA PRODUCTS INC] 12 Current NDC, Legacy NDC, 10 package rows 20240404_be03b588-afbd-41d1-be96-444d735c9768.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 14 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join UV RESTORE FACE SERUM SUNSCREEN SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE COSMAX USA 564b8070-ee59-0c24-e063-6294a90ad9a9 2026-07-10 Warnings Exact identifier application number: M020 COCO-EVE COCONUT MILK BODY SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE COSMAX USA 564b80c2-16e0-fb5f-e063-6394a90a50d2 2026-07-10 Warnings Exact identifier application number: M020 COCO EVE SUNNY HONEY HIGHLIGHTER BODY SPF 50 HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE COSMAX USA 564b9b1f-3d5b-4349-e063-6294a90a3b77 2026-07-10 Warnings Exact identifier application number: M020 NORWEX Lip Glaze Broad Spectrum SPF 30 Hazelnut ZINC OXIDE COSMAX USA 564ba912-c44b-4940-e063-6294a90a28fa 2026-07-10 Warnings Exact identifier application number: M020 MISTINE UV INVISIBLE FACE SHEER SUNSCREEN SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE COSMAX USA 564bbb5f-4000-390d-e063-6294a90a408d 2026-07-10 Warnings Exact identifier application number: M020 PEACH AND LILY SUN COVER MINERAL SUNSCREEN SPF 30 ZINC OXIDE COSMAX USA 564bb5f9-5ac5-548b-e063-6394a90a8462 2026-07-10 Warnings Exact identifier application number: M020 ILLUSION LUMINOUS GLOW FOUNDATION AVOBENZONE, HOMOSALATE, AND OCTISALATE Kingdom Animalia, LLC DBA Hourglass Cosmetics cf6a7e1a-7bca-439c-808a-80262f095f84 2026-07-10 Warnings Exact identifier application number: M020 Tula Skincare Protect and Glow Daily Facial Sunscreen Gel SPF 30 AVOBENZONE, HOMOSALATE, AND OCTISALATE The Procter & Gamble Manufacturing Company 30a063fa-e537-a2c1-e063-6394a90a6a83 2026-07-09 Warnings Exact identifier application number: M020 Olay Complete Lightweight with Sunscreen Broad Spectrum SPF 15 Sensitive OCTINOXATE AND ZINC OXIDE The Procter & Gamble Manufacturing Company 3cb971e1-34f1-ee89-e063-6394a90a52a9 2026-07-09 Warnings Exact identifier application number: M020 Olay Complete Lightweight with Sunscreen Broad Spectrum SPF 30 Sensitive OCTINOXATE, OCTISALATE, OCTOCRYLENE, AND ZINC OXIDE The Procter & Gamble Manufacturing Company 3cb9de81-f05e-9697-e063-6394a90a69c5 2026-07-09 Warnings Exact identifier application number: M020 Bombee Honey Daily Glow Shield Sunscreen HOMOSALATE, OCTISALATE, OCTOCRYLENE, TITANIUM DIOXIDE ABT ASIA Inc. 56112dff-b091-7a56-e063-6294a90a77d3 2026-07-08 Warnings Exact identifier application number: M020 Sunny C Sunscreen SPF 50 SUNNY C SUNSCREEN MIXIK, INC. 4ed2a482-6c63-69f5-e063-6394a90ad3ee 2026-07-08 Warnings Exact identifier application number: M020 Ultra Violette Supreme Screen Broad Spectrum SPF 50 AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Grace and Fire USA Inc. 24389324-19db-7eb5-e063-6394a90ad7fb 2026-07-08 Warnings Exact identifier application number: M020 ANEW ULTIMATE DAY MULTI-PERFORMANCECREAM SPF 25 SUNSCREEN AVOBENZONE, HOMOSALATE, OCTINOXATE,OXYBENZONE COSMAX USA, CORPORATION 562053d4-12bd-976e-e063-6394a90a59de 2026-07-08 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 DERMIO DERMATOLOGY LLC 562f5b0d-6a10-305d-e063-6394a90a5980 2026-07-08 Warnings Exact identifier application number: M020 Stay Ageless Tinted Mineral Sunscreen BROAD SPECTRUM SPF30 Suzanne's Skin2soul LLC 562fbaa6-f93a-5ec4-e063-6294a90a9634 2026-07-08 Warnings Exact identifier application number: M020 Sun Protection Mineral SPF 30 ZINC OXIDE derma e bf6474a7-a21f-49cb-86e6-e5c40dbd34c3 2026-07-08 Warnings Exact identifier application number: M020 Aussie Betta Tallow Sunscreen SPF50 SPF50 TITANIUM DIOXIDE AND ZINC OXIDE SUNSCREEN AUSSIE BETTA HEALTHY CARE PTY LTD 56007d82-ff5b-6c26-e063-6294a90a09b6 2026-07-07 Warnings Exact identifier application number: M020 Bath and Body Works SPF Pink Dream AVOBENZONE,HOMOSALATE,OCTISALATE Bath & Body Works, Inc. 560785f5-9126-12ba-e063-6294a90ac946 2026-07-07 Warnings Exact identifier application number: M020 Bath and Body Works SPF Sunkissed Berry AVOBENZONE,HOMOSALATE,OCTISALATE Bath & Body Works, Inc. 56078698-8655-12bd-e063-6294a90ad34c 2026-07-07 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49967-584-01 49967058401 1 BOTTLE in 1 CARTON (49967-584-01) > 75 mL in 1 BOTTLE 1 bottle 2016-12-21 0000-00-00 No No Current 49967-584-02 49967058402 2 mL in 1 PACKET (49967-584-02) 2 ml 2016-12-21 0000-00-00 No No Current 49967-584-03 49967058403 3 mL in 1 TUBE (49967-584-03) 3 ml 2016-12-21 0000-00-00 No No Current 49967-584-04 49967058404 1 TUBE in 1 CARTON (49967-584-04) / 100 mL in 1 TUBE 1 tube 2022-12-12 0000-00-00 No No Current 49967-584-05 49967058405 1 TUBE in 1 CARTON (49967-584-05) > 75 mL in 1 TUBE 1 tube 2016-12-21 0000-00-00 No No Current 49967-584-06 49967058406 1 TUBE in 1 CARTON (49967-584-06) / 40 mL in 1 TUBE 1 tube 2024-01-01 No No Current