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 191 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Cica Redness Solution Sunscreen ZINC OXIDE Meebak Beauty, Inc 15eea1eb-9468-4611-915d-e43112c4a4f5 2025-08-18 Warnings Exact identifier application number: M020 HAWAIIAN TROPIC AVOBENZONE/OCTOCRYLENE Edgewell Personal Care Brands LLC 3c936ed0-ab7a-ccec-e063-6294a90afd93 2025-08-17 Warnings Exact identifier application number: M020 Banana Boat AVOBENZONE OCTOCRYLENE OXYBENZONE Edgewell Personal Care Brands LLC 0f772b91-e67b-46cf-e054-00144ff8d46c 2025-08-17 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE, OCTOCRYLENE, OXYBENZONE EdgewellPersonal Care Brands LLC 353353b9-54f8-4300-9632-7615de394076 2025-08-17 Warnings Exact identifier application number: M020 BANANA BOAT AVOBENZONE, HOMOSALATE, OCTOCRYLENE Edgewell Personal Care Brands LLC 0c6aeadb-f61d-29e3-e063-6294a90a7473 2025-08-17 Warnings Exact identifier application number: M020 MOISTURE SURGE SPF AVOBENZONE,HOMOSALATE,OCTINOXATE,OCTISALATE CLINIQUE LABORATORIES LLC ec921e21-db68-db77-e053-2a95a90a5781 2025-08-15 Warnings Exact identifier application number: M020 Olay Invisible Sunscreen Facial Primer plus Sunscreen Broad Spectrum SPF 35 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE The Procter & Gamble Manufacturing Company 3c69f096-1575-309b-e063-6394a90a7229 2025-08-15 Warnings Exact identifier application number: M020 MOISTURE SURGE CC BROAD SPECTRUM SPF 30 HYDRATING COLOUR CORRECTOR OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, AND ZINC OXIDE CLINIQUE LABORATORIES LLC ea4d564f-ac64-abac-e053-2a95a90a8abb 2025-08-15 Warnings Exact identifier application number: M020 Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Sunset Cove Carded HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE Sun Bum, LLC 3ac67c26-d56e-32a9-e063-6294a90a1048 2025-08-15 Warnings Exact identifier application number: M020 Sun Bum Signature High Performance Mineral Sunscreen Broad Spectrum SPF 50 ZINC OXIDE Sun Bum, LLC 3aa13423-045a-7227-e063-6294a90ae49b 2025-08-15 Warnings Exact identifier application number: M020 Sun Bum Daily Sunscreen Mist Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3a796a0b-8021-9a9f-e063-6294a90a6eb2 2025-08-15 Warnings Exact identifier application number: M020 SOLARA SUNCARE - DAY DREAMER SPF 30 ZINC OXIDE SOLARA SUNCARE, INC. 3c6c9266-a7ff-19f4-e063-6294a90a6096 2025-08-15 Warnings Exact identifier application number: M020 Sun Bum Mineral 30 Sheer Sunscreen Face ZINC OXIDE Sun Bum, LLC 3b00c2d6-a55d-0a56-e063-6294a90ac4b8 2025-08-15 Warnings Exact identifier application number: M020 Sun Bum Mineral 30 Sunscreen 3 OZ ZINC OXIDE Sun Bum, LLC 3b014bd6-ba40-9003-e063-6394a90ab451 2025-08-15 Warnings Exact identifier application number: M020 Ocean Potion Suncare Mineral 30 Zinc Oxide Sunscreen ZINC OXIDE GNL BRANDS INTERNATIONAL, LLC 3c6e7e62-4313-cbce-e063-6394a90ac382 2025-08-15 Warnings Exact identifier application number: M020 Ocean Potion Face with Clear Zinc Oxide Broad Spectrum SPF 50 Sunscreen OCTOCRYLENE, ZINC OXIDE GNL BRANDS INTERNATIONAL, LLC 3c6f3e0b-2dff-6dc3-e063-6394a90abb0e 2025-08-15 Warnings Exact identifier application number: M020 EltaMD UV Daily Hydration OCTISALATE, ZINC OXIDE SUNSCREEN CP Skin Health Group, Inc. bfdb266b-9920-4225-84c7-bcbad81fd1c7 2025-08-15 Warnings Exact identifier application number: M020 Sun Bum 70 Premium Moisturizing Sunscreen 8 OZ AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 39fb5e66-5172-3b83-e063-6394a90aab2d 2025-08-14 Warnings Exact identifier application number: M020 Sun Bum Face Cream 50 Premium Sunscreen HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE Sun Bum, LLC 3c57fcf7-7816-8197-e063-6394a90af80a 2025-08-14 Warnings Exact identifier application number: M020 Sun Bum 50 Premium Moisturizing Sunscreen Roll-On AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3c58c9c7-ca9e-d012-e063-6394a90a5aa9 2025-08-14 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