Home NDC 69625-583 La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen
Product NDC 69625-583
11-digit product format 696250583
Labeler code 69625
Product ID 69625-583_ac7275a0-234a-4918-befd-5e2a0d6c1133
Type HUMAN OTC DRUG
Nonproprietary name Avobenzone, Homosalate, Octisalate and Octocrylene
Dosage form LOTION
Route TOPICAL
Labeler Cosmetique Active Production
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 2026-12-31
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 UV Broad Spectrum SPF 30 Sunscreen
Listing expiration 2026-12-31 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 69625-583-01 La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen 75 mL in 1 BOTTLE LOTION 75 3 69625-583-01 La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen 1 in 1 CARTON LOTION 1 3 69625-583-02 La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen 2 mL in 1 PACKET LOTION 2 3 69625-583-03 La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen 3 mL in 1 TUBE LOTION 3 3 69625-583-04 La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen 100 mL in 1 TUBE LOTION 100 3 69625-583-04 La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen 1 in 1 CARTON LOTION 1 3 69625-583-05 La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen 1 in 1 CARTON LOTION 1 3 69625-583-05 La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen 75 mL in 1 TUBE LOTION 75 3 69625-583-06 La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen 1 in 1 CARTON LOTION 1 3 69625-583-06 La Roche Posay Laboratoire Dermatologique Toleriane Double Repair UV Broad Spectrum SPF 30 Sunscreen 40 mL in 1 TUBE LOTION 40 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69625-583 LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE TOLERIANE DOUBLE REPAIR UV BROAD SPECTRUM SPF 30 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE) LOTION [COSMETIQUE ACTIVE PRODUCTION] 3 Current NDC, 10 package rows 20240410_f9645435-e138-45df-a5ec-6dc7b3ff792d.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 210 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Noevir Raysela UV Shield Primer ZINC OXIDE, OCTINOXATE Nippon Shikizai, Inc. 45030b2f-21cf-4285-af12-87ea8f0b8df7 2025-05-14 Warnings Exact identifier application number: M020 OS-01 Lip SPF BS SPF15 ZINC OXIDE ONESKIN INC. 351d55f6-fcd9-1d47-e063-6294a90a2cf0 2025-05-14 Warnings Exact identifier application number: M020 NATUREWELL HYDRASUN LIP BALM SPF30 MINT BREEZE SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALM Port Jervis Laboratories, Inc. 350cd329-8fe2-314f-e063-6394a90ac954 2025-05-13 Warnings Exact identifier application number: M020 Lancer Mineral Sun Shield Universal Tint Broadspectrum SPF 30 ZINC OXIDE Lancer Skincare LLC 522a9158-2fd1-4634-adef-2ba84c86bcd7 2025-05-13 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE Navajo Manufacturing Company Inc. 33f13aa4-9279-c251-e063-6294a90a2d67 2025-05-12 Warnings Exact identifier application number: M020 OS-01 FACE SPF BS SPF 30 TINTED DEEP ZINC OXIDE Allure Labs 34f51ff4-541d-2b2e-e063-6394a90a39da 2025-05-12 Warnings Exact identifier application number: M020 Bright Guard Natural SPF 30 ZINC OXIDE Renu Laboratories, LLC e7035fcd-6894-3360-e053-2a95a90a6f1d 2025-05-12 Warnings Exact identifier application number: M020 Bright Guard Sport SPF ZINC SPF RENU LABORATORIES, LLC c9b48a9e-d69f-65a7-e053-2995a90a0baf 2025-05-12 Warnings Exact identifier application number: M020 OS-01 FACE SPF BD SPF 30 TINTED MEDIUM/DEEP ZINC OXIDE Allure Labs 34f674c1-5d59-915a-e063-6394a90a6c2f 2025-05-12 Warnings Exact identifier application number: M020 Meaningful Beauty Cindy Crawford Skin Brightening Decollete and Neck Treatment Broad Spectrum SPF 15 AVOBENZONE, OCTINOXATE, OCTISALATE AND OXYBENZONE Meaningful Beauty, LLC f59fe019-569b-49ba-accf-fa4d356ce96b 2025-05-12 Warnings Exact identifier application number: M020 Cicatricure Gold Lift SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Genomma Lab USA 34cc5b3c-af36-e202-e063-6294a90a13a7 2025-05-10 Warnings Exact identifier application number: M020 Mineral Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE The Maui Medical Group, Inc 34b6aa46-657b-2676-e063-6294a90abadd 2025-05-09 Exact identifier application number: M020 Tinted Lip Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Scottsdale Skin Boutique and Dermatology Pllc 34a5a99f-9e22-52ab-e063-6294a90a9323 2025-05-08 Exact identifier application number: M020 Powder TITANIUM DIOXIDE Oxygen Development LLC 08b7eeeb-09ae-ffe6-e063-6294a90aba90 2025-05-07 Warnings Exact identifier application number: M020 cle de peau BEAUTE UV PROTECTIVE N AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Shiseido Americas Corporation fe19a057-a3c6-4c53-92f9-a4a960cd5b08 2025-05-07 Warnings Exact identifier application number: M020 Winter Survival Kit OCTINOXATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE Duke Cannon Supply Co. 2487ab56-7856-66b0-e063-6394a90a9d87 2025-05-07 Warnings Exact identifier application number: M020 OS-01 Lip SPF BS SPF15 ZINC OXIDE Allure Labs 3490ed60-60b9-dfcd-e063-6394a90ab17a 2025-05-07 Warnings Exact identifier application number: M020 Lip Love Moisture Balm SPF30 - Nude Beige ZINC OXIDE Koco Life LLC 3491084b-348a-f2bf-e063-6394a90abd25 2025-05-07 Warnings Exact identifier application number: M020 Lip Love Moisture Balm SPF30 - Watermelon ZINC OXIDE Koco Life LLC 3491fb2a-d55f-1736-e063-6294a90a594a 2025-05-07 Warnings Exact identifier application number: M020 Abib Heartleaf mild sunscreen Relief tube ZINC OXIDE FOURCOMPANY CO., LTD. 34965587-c9b7-4066-e063-6394a90ab424 2025-05-07 Warnings Exact identifier application number: M020
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 69625-583-01 69625058301 75 mL in 1 BOTTLE 75 ml Historical 69625-583-02 69625058302 2 mL in 1 PACKET (69625-583-02) 2 ml 2016-12-21 No No Current 69625-583-03 69625058303 3 mL in 1 TUBE (69625-583-03) 3 ml 2016-12-21 No No Current 69625-583-04 69625058304 1 TUBE in 1 CARTON (69625-583-04) / 100 mL in 1 TUBE 1 tube 2022-12-12 No No Current 69625-583-05 69625058305 1 in 1 CARTON Historical 69625-583-06 69625058306 1 TUBE in 1 CARTON (69625-583-06) / 40 mL in 1 TUBE 1 tube 2024-01-01 No No Current