Home NDC 49967-199 LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Broad Spectrum SPF 50 Sunscreen Skin Protectant
Product NDC 49967-199
11-digit product format 499670199
Labeler code 49967
Product ID 49967-199_b2f0c42f-aea9-413f-8d08-da5bcec7dfc7
Type HUMAN OTC DRUG
Nonproprietary name Dimethicone, Homosalate, Octisalate, Octocrylene and Zinc oxide
Dosage form CREAM
Route TOPICAL
Labeler L�Oreal USA Products Inc
Application M020
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-01
Substance HOMOSALATE; OCTISALATE; DIMETHICONE; OCTOCRYLENE; ZINC OXIDE
Active strength 80; 50; 10; 50; 70 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
Pharmacologic classes Skin Barrier Activity [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes 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 Cicaplast Balm B5 UV Broad Spectrum SPF 50 Sunscreen Skin Protectant
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HOMOSALATE 80 mg/mL OCTISALATE 50 mg/mL DIMETHICONE 10 mg/mL OCTOCRYLENE 50 mg/mL ZINC OXIDE 70 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 5 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 49967-199-01 LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Broad Spectrum SPF 50 Sunscreen Skin Protectant 1 in 1 CARTON CREAM 1 1 49967-199-01 LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Broad Spectrum SPF 50 Sunscreen Skin Protectant 40 mL in 1 TUBE CREAM 40 1 49967-199-02 LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Broad Spectrum SPF 50 Sunscreen Skin Protectant 20 in 1 PACKAGE CREAM 20 1 49967-199-02 LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Broad Spectrum SPF 50 Sunscreen Skin Protectant 5 mL in 1 TUBE CREAM 5 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49967-199 LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE CICAPLAST BALM B5 UV BROAD SPECTRUM SPF 50 SUNSCREEN SKIN PROTECTANT (DIMETHICONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDE) CREAM [L’OREAL USA PRODUCTS INC] 1 Current NDC, 4 package rows 20241225_e8539a43-db85-451c-bce8-2c488f3dc40d.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 176 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Baby Rose ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0e9d9419-a7e1-bc42-e063-6394a90af511 2025-10-20 Warnings Exact identifier application number: M020 ATTITUDE Oceanly Phyto-Sun Tinted Shimmer Cream SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0e8af968-77d5-1dcd-e063-6394a90a6699 2025-10-20 Warnings Exact identifier application number: M020 ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Peachy Shell ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0e9e95c3-4ac8-5962-e063-6294a90a0c02 2025-10-20 Warnings Exact identifier application number: M020 ATTITUDE Oceanly Phyto-sun lip balm SPF 30 Terracotta ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0e9dd230-b087-cda7-e063-6394a90ae084 2025-10-20 Warnings Exact identifier application number: M020 ATTITUDE Oceanly Phyto-Sun Tinted Oil SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0e9b0642-53ed-ec94-e063-6394a90aec3d 2025-10-20 Warnings Exact identifier application number: M020 ATTITUDE Oceanly Phyto-Sun Tinted Cream SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0d977158-8b5d-66ac-e063-6294a90a4d5c 2025-10-20 Warnings Exact identifier application number: M020 ATTITUDE Oceanly Phyto-Sun Kit SPF 30 ZINC OXIDE 9055-7588 Quebec Inc. DBA Attitude 0eae4b71-60be-9715-e063-6294a90af463 2025-10-20 Warnings Exact identifier application number: M020 Attitude Oceanly Phyto-Sun Tinted - SPF 15 - Broad Spectrum Sunscreen ZINC OXIDE Attitude DBA 9055-7588 Qubec Inc. 9ed70230-980c-474c-9f72-a6be0f355124 2025-10-20 Warnings Exact identifier application number: M020 HAWAIIAN TROPIC AVOBENZONE OCTISALATE OCTOCRYLENE Edgewell Personal Care Brands LLC 419b8043-7921-ca77-e063-6394a90a99ba 2025-10-20 Warnings Exact identifier application number: M020 Illuminizing Blendrops Broad Spectrum SPF 46 HOMOSALATE, OCTISALATE, ZINC OXIDE Wasatch Product Development, LLC 419c8718-6b9e-3df7-e063-6294a90a1e3b 2025-10-20 Warnings Exact identifier application number: M020 Sonni SunDay Serum ZINC OXIDE Sonni 419d4ada-fe9b-b774-e063-6394a90a3d09 2025-10-20 Warnings Exact identifier application number: M020 Lip Clear Lysine Plus Coldstick OCTINOXATE AND OXYBENZONE Quantum, Inc. 66f84e56-4a5d-4b71-8bd3-79961e7bf4fe 2025-10-20 Warnings Exact identifier application number: M020 Super Lysine Plus Strawberry Lip Treatment OCTINOXATE AND OXYBENZONE Quantum, Inc. 2cafc97f-4cd3-4755-b394-3802c28d4ed5 2025-10-20 Warnings Exact identifier application number: M020 Super Lysine Plus Tangerine Lip Treatment OCTINOXATE AND OXYBENZONE Quantum, Inc. 8a00194e-9e28-4257-82e5-59bc44f7897d 2025-10-20 Warnings Exact identifier application number: M020 Super Lysine Plus Coldstick OCTINOXATE AND OXYBENZONE Quantum, Inc. c9318a8c-ba3b-4068-84df-110c9005ee1d 2025-10-20 Warnings Exact identifier application number: M020 Terez Honor Hydro Sunscreen AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE DEWYCREAM INC 418d054b-436f-6aa3-e063-6294a90a0f56 2025-10-19 Warnings Exact identifier application number: M020 Danahan Moisture Daily Sunscreen Broad Spectrum SPF 50 ENSULIZOLE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE Cosmocos Co., Ltd 41129799-85ed-2de2-e063-6394a90ab40c 2025-10-17 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 70 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC c5a67314-e5b2-4dd6-94e9-39c2f286c346 2025-10-17 Warnings Exact identifier application number: M020 LION POSE GHOST-BUSTER BROAD SPECTRUM SPF 42 SUNSCREEN ZINC OXIDE Lion Pose Inc. 0310407b-fb74-aa8b-e063-6294a90ad841 2025-10-17 Warnings Exact identifier application number: M020 Thrive Daily Defense Sunscreen Balm SPF30 ZINC OXIDE Thrive Natural Care, Inc 1266bd05-1971-a7f0-e063-6394a90a089c 2025-10-17 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 49967-199-01 49967019901 1 TUBE in 1 CARTON (49967-199-01) / 40 mL in 1 TUBE 1 tube 2024-06-01 No No Current 49967-199-02 49967019902 20 TUBE in 1 PACKAGE (49967-199-02) / 5 mL in 1 TUBE 20 tube 2024-06-01 No No Current