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 190 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Sun Bum 30 Mineral Sunscreen Lip Balm ZINC OXIDE Sun Bum, LLC 3cbfba65-5702-50b5-e063-6394a90a409d 2025-08-19 Warnings Exact identifier application number: M020 Sun Bum Signature High Performance Mineral Sunscreen Face Stick Tinted 50 ZINC OXIDE Sun Bum, LLC 324e8ddb-89d2-08ca-e063-6294a90ab6c1 2025-08-19 Warnings Exact identifier application number: M020 Sun Bum 70 Premium Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3b02811d-dc66-fc6f-e063-6294a90aefc8 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum Kids 50 Clear Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3b058b74-27d0-8f8a-e063-6294a90aa02c 2025-08-18 Warnings Exact identifier application number: M020 PLAY Mineral Stick SPF 50 with Olive Fruit Extract ZINC OXIDE Supergoop LLC 3ca7e1ed-7cc7-76b0-e063-6394a90ade93 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum Mineral 30 Sunscreen 6 OZ ZINC OXIDE Sun Bum, LLC 3b91a7e3-ce52-6aa0-e063-6394a90a15e7 2025-08-18 Warnings Exact identifier application number: M020 CoTZ Kids ZINC OXIDE Fallien Cosmeceuticals, LTD. 3ca8742f-67cb-a25c-e063-6394a90a4638 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum 30 Premium Moisturizing Sunscreen 8 OZ AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3b154009-9c6f-eadf-e063-6394a90ae424 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum Kids 50 Clear Sunscreen 6 OZ AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3b162348-0222-490e-e063-6394a90ad494 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum 50 Premium Moisturizing Sunscreen 1.75 OZ AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3b169860-66bc-dd02-e063-6294a90a7974 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum 30 Mineral Sunscreen Face 1.7 OZ TITANIUM DIOXIDE, ZINC OXIDE Sun Bum, LLC 3b1729c5-d8ca-94c7-e063-6394a90a67a5 2025-08-18 Warnings Exact identifier application number: M020 CoTZ Kids ZINC OXIDE Fallien Cosmeceuticals, LTD. 3ca914e2-cd53-42bf-e063-6294a90a7082 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum Daily Mineral Sunscreen Moisturizer Broad Spectrum SPF 30 ZINC OXIDE Sun Bum, LLC 3b1a0596-b852-16be-e063-6394a90a3498 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum Signature Clear High Performance Sunscreen Broad Spectrum SPF 50 1.5 OZ OCTISALATE, OCTOCRYLENE, ZINC OXIDE Sun Bum, LLC 3b29dbfc-0b92-eb0f-e063-6294a90a16e1 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum 30 Mineral Sunscreen 32 OZ ZINC OXIDE Sun Bum, LLC 3b2cb7cf-7e2c-0fd2-e063-6294a90a3b17 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum Sunscreen Oil 50 5 OZ AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3b2b4ba0-3f89-0a04-e063-6294a90ac1c0 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum Signature Sunscreen Premium Zinc Lip Balm Broad Spectrum SPF 30 ZINC OXIDE Sun Bum, LLC 3ca9e9d3-1c73-7bd6-e063-6394a90ad204 2025-08-18 Warnings Exact identifier application number: M020 Ocean Potion Suncare Mineral 50 Essential Scent of Sunshine Zinc Oxide Continuous Sunscreen ZINC OXIDE GNL BRANDS INTERNATIONAL, LLC 3caaea85-0dfe-6f69-e063-6294a90a7d4a 2025-08-18 Warnings Exact identifier application number: M020 PLAY Lip Shield SPF 30 - Mint AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Supergoop LLC 3cab1a7d-6226-9eba-e063-6294a90a8c4d 2025-08-18 Warnings Exact identifier application number: M020 Sun Bum Broad Spectrum SPF 30 5 OZ AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3cad0757-3155-c716-e063-6294a90ad7a9 2025-08-18 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