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 187 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PHOFAY Matte Sunscreen Liquid Foundation SPF 30 3 ENSULIZOLE ,HOMOSALATE,OCTINOXATE,TITANIUM DIOXIDE Hangzhou Jingshen Trading Co., Ltd. 3d565612-ade5-bfb3-e063-6294a90a0c65 2025-08-27 Warnings Exact identifier application number: M020 Jack Black Double Duty AVOBENZONE OCTOCRYLENE Jack Black L.L.C. 36d81d6d-4f9b-692d-e063-6294a90ad559 2025-08-27 Warnings Exact identifier application number: M020 Sun Bum Tinted Sunscreen Lip Balm Broad Spectrum SPF 15 - Sandbar HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE Sun Bum, LLC 3ac57c70-9298-cbe7-e063-6394a90aefc1 2025-08-27 Warnings Exact identifier application number: M020 Sun Bum 30 Mineral Tinted Sunscreen Face TITANIUM DIOXIDE, ZINC OXIDE Sun Bum, LLC 3a290aad-7f40-cb10-e063-6394a90a2e69 2025-08-27 Warnings Exact identifier application number: M020 Broad Spectrum SPF 30 sunscreen HOMOSALATE 7.5%, OCTISALATE 5.0%, AVOBENZONE 3.0% Florida Squeezed a01f0ab9-d686-4ee1-be39-fd4c061cb018 2025-08-26 Warnings Exact identifier application number: M020 Sun Bum 50 Mineral Sunscreen Face Stick ZINC OXIDE Sun Bum, LLC 3d48d467-4b6b-c477-e063-6294a90a5a0d 2025-08-26 Warnings Exact identifier application number: M020 PAPATUI Facial Moisturizer Broad Spectrum SPF 30 ZINC OXIDE PAPATUI, LLC 3d4ab3a5-a29b-bdd9-e063-6294a90a542c 2025-08-26 Warnings Exact identifier application number: M020 Broad Spectrum SPF 50 sunscreen HOMOSALATE 10%, OCTISALATE 5.0%, AVOBENZONE 3.0% Florida Squeezed 34ffc25c-16e3-4c7c-9d46-9d9f279c074b 2025-08-26 Warnings Exact identifier application number: M020 Premium Moisturizing Sunscreen Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 36da7117-1c8e-7fcf-e063-6294a90aed00 2025-08-26 Warnings Exact identifier application number: M020 Sun Bum Premium Sunscreen Face Stick Broad Spectrum SPF 30 Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 36dc7c13-eaf7-b415-e063-6294a90a5784 2025-08-26 Warnings Exact identifier application number: M020 Sun Bum Face 50 Premium Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3c1b7f0c-fdc2-df22-e063-6294a90aed41 2025-08-26 Warnings Exact identifier application number: M020 Sun Bum Mist 45 Refreshing Sunscreen 3.4 OZ AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3c1c8b83-f37d-a29d-e063-6294a90a20a8 2025-08-26 Warnings Exact identifier application number: M020 Sun Bum 15 Premium Sunscreen Tanning Oil AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3c468710-ca71-79be-e063-6394a90a8cfd 2025-08-26 Warnings Exact identifier application number: M020 Coco and Eve Sunny Honey Protect SPF 50 Highlighter Body SPF 50 SUNSCREEN Soleil Collective LLC 3d4c90e7-0716-4d57-e063-6394a90a43fa 2025-08-26 Warnings Exact identifier application number: M020 Sun Bum 70 Premium Moisturizing Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE Sun Bum, LLC 3c4433e2-d383-8326-e063-6294a90aaf98 2025-08-26 Warnings Exact identifier application number: M020 Coco and Eve Sunny Honey Protect SPF 50 Coconut Milk Body SPF 50 SUNSCREEN Soleil Collective LLC 3d4d1b94-b1ce-cf94-e063-6394a90a61ba 2025-08-26 Warnings Exact identifier application number: M020 naked TURTLE 30 ZINC OXIDE NAKED TURTLE SUNSCREEN LLC 65f1570a-6156-40e6-a792-e0707607dc2f 2025-08-26 Warnings Exact identifier application number: M020 Sky and Sol Sunscreen SPF 50 ZINC OXIDE Delta Ecommerce LLC 2d490531-af38-87d0-e063-6394a90acf49 2025-08-25 Warnings Exact identifier application number: M020 Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF 50 Plus AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 20d24c9d-9558-156d-e063-6294a90a2d1a 2025-08-25 Warnings Exact identifier application number: M020 Neutrogena Sport Face Oil Free Sunscreen Broad Spectrum SPF 70 Plus AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 413275e8-0011-471e-9539-ea95ed838413 2025-08-25 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