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 92 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Royal Jelly Radiance Foundation Broad Spectrum SPF 20 Earth OCTINOXATE, ZINC OXIDE Distribuidora Comercial Jafra, S.A. de C.V. 0edc7bd4-9350-48e1-bbfe-e6450458ae59 2025-12-31 Warnings Exact identifier application number: M020 Radiance Foundation Broad Spectrum SPF 20 - Bronze OCTINOXATE, ZINC OXIDE Distribuidora Comercial Jafra, S.A. de C.V. 90fbf555-106c-4131-b572-ead9bbb246e6 2025-12-31 Warnings Exact identifier application number: M020 Radiance Foundation Broad Spectrum SPF 20 - Honey OCTINOXATE, ZINC OXIDE Distribuidora Comercial Jafra, S.A. de C.V. 1accbe67-c722-4af7-8422-0559ac4a987a 2025-12-31 Warnings Exact identifier application number: M020 Radiance Foundation Broad Spectrum SPF 20 - Bare OCTINOXATE, ZINC OXIDE Distribuidora Comercial Jafra, S.A. de C.V. 5c0805c7-9b92-4c08-877c-64e720308430 2025-12-31 Warnings Exact identifier application number: M020 Radiance Foundation Broad Spectrum SPF 20- Natural OCTINOXATE, ZINC OXIDE Distribuidora Comercial Jafra, S.A. de C.V. 0cc5429d-ace4-4060-b993-1b607218eaf8 2025-12-31 Warnings Exact identifier application number: M020 Radiance Foundation Broad Spectrum SPF 20-Nude OCTINOXATE, ZINC OXIDE Distribuidora Comercial Jafra, S.A. de C.V. b1851c5d-32ad-482a-bd24-2f280a68ef9e 2025-12-31 Warnings Exact identifier application number: M020 Radiance Foundation Broad Spectrum SPF 20 -Spice OCTINOXATE, ZINC OXIDE Distribuidora Comercial Jafra, S.A. de C.V. 6164dc23-81c2-48b8-b309-2c5a81fe13a4 2025-12-31 Warnings Exact identifier application number: M020 Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Light Medium OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 4744e501-f12a-6d25-e063-6394a90a2574 2025-12-31 Warnings Exact identifier application number: M020 Radiance Foundation Broad Spectrum SPF 20 - Tawny OCTINOXATE, ZINC OXIDE Distribuidora Comercial Jafra, S.A. de C.V. d7c4e758-3af2-40c6-bbe1-37e6fd0a5eb6 2025-12-31 Warnings Exact identifier application number: M020 Radiance Foundation Broad Spectrum SPF 20 - Cappuccino OCTINOXATE, ZINC OXIDE Distribuidora Comercial Jafra, S.A. de C.V. 30601a73-089e-4fa7-8fb7-6b108498934a 2025-12-31 Warnings Exact identifier application number: M020 Good Karma Dry Oil Mineral Sunscreen SPF-30 ZINC OXIDE SUNSCREEN SOLARA SUNCARE, INC. 209c4913-29e6-24ca-e063-6294a90a6872 2025-12-31 Warnings Exact identifier application number: M020 Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Medium OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 47456bf5-9f6c-e6a5-e063-6294a90a7054 2025-12-31 Warnings Exact identifier application number: M020 Olay Age Defying Classic Daily Renewal Broad Spectrum SPF 15 OCTINOXATE AND ZINC OXIDE The Procter & Gamble Manufacturing Company 60183a47-fd02-052b-e053-2991aa0a1b5c 2025-12-31 Warnings Exact identifier application number: M020 Native Mineral Sunscreen Broad Spectrum SPF 30 Sweet Peach and Nectar ZINC OXIDE The Procter & Gamble Manufacturing Company 026dcaee-d33c-b874-e063-6394a90ad2e7 2025-12-31 Warnings Exact identifier application number: M020 Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 4745ab56-abaa-42de-e063-6394a90a6310 2025-12-31 Warnings Exact identifier application number: M020 Olay Complete Plus Daily Facial Moisturizer with Sunscreen Broad Spectrum SPF 40 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE The Procter & Gamble Manufacturing Company 22f645cf-5182-9e3f-e063-6394a90adc84 2025-12-31 Warnings Exact identifier application number: M020 Native Mineral Sunscreen Broad Spectrum SPF 30 Tropical Breeze ZINC OXIDE The Procter & Gamble Manufacturing Company 232032b7-803f-40ec-e063-6394a90a4b38 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Sport Sunscreen SPF 100 AVOBENZONE 3%, HOMOSALATE 15%, OCTINOXATE 2% OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6% Beiersdorf Inc e1a9a831-a0b9-17ba-e053-2a95a90a3fa7 2025-12-31 Warnings Exact identifier application number: M020 Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan Deep OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Pur-lisse Beauty, LLC 4745ebec-acb0-77c4-e063-6394a90aee07 2025-12-31 Warnings Exact identifier application number: M020 Coppertone Pure and Simple Baby Sunscreen SPF 50 ZINC OXIDE 24.08% Beiersdorf Inc 08134b95-1879-27e5-e063-6294a90a29af 2025-12-31 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