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 147 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Mineral Based Foam Sunscreen Tinted TITANIUM DIOXIDE, ZINC OXIDE KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION 32465271-abb9-d03f-e063-6294a90a990e 2025-12-08 Exact identifier application number: M020 Mineral Based Foam Sunscreen Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION 32486bfb-0cc8-0283-e063-6394a90a9967 2025-12-08 Exact identifier application number: M020 Harrys Daily Facial SPF Broad Spectrum ZINC OXIDE Harry's, Inc. 39fdde34-45ec-bc22-e063-6394a90a7dce 2025-12-08 Warnings Exact identifier application number: M020 Healthy Mineral Sunscreen Brightening plus Tint ZINC OXIDE ZEN DERMATOLOGY, INC. 31e32e9c-9e0b-b678-e063-6294a90a66f5 2025-12-08 Exact identifier application number: M020 Healthy Mineral Sunscreen No Shine plus Tint ZINC OXIDE Zen Dermatology, Inc. 31576340-cb11-d944-e063-6294a90adef2 2025-12-08 Warnings Exact identifier application number: M020 Healthy Mineral Sunscreen No Shine - No Tint TITANIUM DIOXIDE, ZINC OXIDE Zen Dermatology, Inc. 31572a16-5f60-565f-e063-6394a90ab8c9 2025-12-08 Warnings Exact identifier application number: M020 Healthy Mineral Sunscreen Face and Body ZINC OXIDE Zen Dermatology, Inc. 31e376b4-098f-34d7-e063-6394a90a1772 2025-12-08 Exact identifier application number: M020 AcneFix Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ACNEFIX INC. 315894b7-ac1b-0982-e063-6294a90ab879 2025-12-08 Exact identifier application number: M020 Shunly Natural Cover SPF50 TITANIUM DIOXIDE, ZINC OXIDE Shunly Skin Care a64e373b-b3f6-4024-b5f5-253783485cd6 2025-12-08 Warnings Exact identifier application number: M020 AcneFix Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE ACNEFIX INC. 31583c7e-365a-d899-e063-6394a90aa63f 2025-12-08 Exact identifier application number: M020 Mineral Fusion Tinted TITANIUM DIOXIDE, ZINC OXIDE FOREFRONT DERMATOLOGY, S.C. 334ec844-5560-50f7-e063-6394a90a01be 2025-12-08 Exact identifier application number: M020 Mineral Fusion Tinted TITANIUM DIOXIDE, ZINC OXIDE FOREFRONT DERMATOLOGY, S.C. 334f90d6-68e5-db37-e063-6294a90a5fb1 2025-12-08 Exact identifier application number: M020 Skin Apeel Pure Protect SPF 40 Broad Spectrum ZINC OXIDE Skin Apeel, Inc. 18e78c7f-1523-a4f4-e063-6394a90aed97 2025-12-08 Warnings Exact identifier application number: M020 Silk Screen TITANIUM DIOXIDE, ZINC OXIDE Skin Apeel, Inc. 3c44baf4-9555-faad-e063-6294a90ab24f 2025-12-08 Warnings Exact identifier application number: M020 Glow Stick TITANIUM DIOXIDE, ZINC OXIDE Skin Apeel, Inc. 3c54b857-c017-a953-e063-6394a90a38df 2025-12-08 Warnings Exact identifier application number: M020 Lip Shield TITANIUM DIOXIDE, ZINC OXIDE Skin Apeel, Inc. 3c545e55-3f55-842b-e063-6394a90ae48e 2025-12-08 Warnings Exact identifier application number: M020 Bare Barrier Sport TITANIUM DIOXIDE, ZINC OXIDE Skin Apeel, Inc. 3c580794-eda3-de57-e063-6294a90a0303 2025-12-08 Warnings Exact identifier application number: M020 Flawless Brightening Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Flawless Skin Care LLC 312e9ca0-a388-a546-e063-6294a90a15d6 2025-12-08 Warnings Exact identifier application number: M020 Mineral SPF 40, protect TITANIUM DIOXIDE, ZINC OXIDE Acne Specialists LLC 2f8859cf-8277-6ea9-e063-6294a90a1a75 2025-12-08 Warnings Exact identifier application number: M020 Mineral SPF 40, Tinted TITANIUM DIOXIDE, ZINC OXIDE Acne Specialists LLC 2fb19ed7-8cee-ce80-e063-6394a90ad3dc 2025-12-08 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