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 138 of 353 · 7,049 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join SHADED TITANIUM DIOXIDE, ZINC OXIDE Potency No. 710 LLC 3117e138-83a1-0931-e063-6394a90abe43 2025-12-10 Warnings Exact identifier application number: M020 SHADED TITANIUM DIOXIDE, ZINC OXIDE Potency No. 710 LLC 31188175-a4ca-449f-e063-6394a90a3c05 2025-12-10 Warnings Exact identifier application number: M020 COVERED ZINC OXIDE Potency No. 710 LLC 3118c3ed-f0f0-f997-e063-6294a90a53a9 2025-12-10 Warnings Exact identifier application number: M020 COVERED ZINC OXIDE Potency No. 710 LLC 3117faeb-1792-1b2e-e063-6294a90a92df 2025-12-10 Warnings Exact identifier application number: M020 Non-Tinted Mineral Foaming Sunscreen TITANIUM DIOXIDE, ZINC OXIDE Restore Skin Therapy, LLC 364b6af2-a0ed-4a17-e063-6394a90a3a17 2025-12-10 Exact identifier application number: M020 Morning Replenish ZINC OXIDE Restore Skin Therapy, LLC 364b26c2-a1bb-9660-e063-6294a90a14d1 2025-12-10 Exact identifier application number: M020 Glass Skin Sunscreen Tinted ZINC OXIDE Fleur de Lune, LLC 34288989-35b8-3aa3-e063-6394a90ac2c4 2025-12-10 Exact identifier application number: M020 Glass Skin Sunscreen Tinted ZINC OXIDE Fleur de Lune, LLC 3418394b-fede-65ce-e063-6394a90ad5f9 2025-12-10 Exact identifier application number: M020 Glass Skin Sunscreen Non-Tinted ZINC OXIDE Fleur de Lune, LLC 341871e5-c170-7560-e063-6394a90a8eee 2025-12-10 Exact identifier application number: M020 Glass Skin Sunscreen Non-Tinted ZINC OXIDE Fleur de Lune, LLC 3428bdbb-1f18-a29b-e063-6294a90addbc 2025-12-10 Exact identifier application number: M020 Sheer Facial Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE BB MEDICAL & DERMATOLOGY INC 342b2403-4f4a-3e77-e063-6294a90a4f0a 2025-12-10 Exact identifier application number: M020 Sheer Mineral Sunscreen Bar TITANIUM DIOXIDE, ZINC OXIDE BB MEDICAL & DERMATOLOGY INC 342b69d5-f0e1-99cd-e063-6294a90abb6e 2025-12-10 Exact identifier application number: M020 Sheer Facial Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE BB MEDICAL & DERMATOLOGY INC 342c3f42-c17f-f777-e063-6394a90a8058 2025-12-10 Exact identifier application number: M020 Lip SPF TITANIUM DIOXIDE, ZINC OXIDE FRANCISCO FLORES, M.D., P.A. 396d3fdd-99d8-77e8-e063-6294a90aec2f 2025-12-10 Exact identifier application number: M020 Non-Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE FRANCISCO FLORES, M.D., P.A. 396cae82-7641-e1b2-e063-6394a90a7c07 2025-12-10 Exact identifier application number: M020 Solar Knight SPF 40 Broad Spectrum TITANIUM DIOXIDE, ZINC OXIDE MASCARENAS ENTERPRISES, INC. 36c27c91-22ac-205c-e063-6294a90ab379 2025-12-10 Exact identifier application number: M020 Tinted Mineral Sunscreen TITANIUM DIOXIDE, ZINC OXIDE FRANCISCO FLORES, M.D., P.A. 396ce15a-06ad-4055-e063-6294a90a27fb 2025-12-10 Exact identifier application number: M020 Dermablue Daily Replenishing ZINC OXIDE Dermablue, P.C. 308da9c9-544e-d5d1-e063-6294a90aa49b 2025-12-10 Warnings Exact identifier application number: M020 Recoverie Mineral Matte ZINC OXIDE Clear Day Acne Clinic 308f41de-fb14-40f9-e063-6394a90a008f 2025-12-10 Warnings Exact identifier application number: M020 AL0043600 Alba Botanica VE Herbal Healing Body COLLOIDAL OATMEAL The Hain Celestial Group, Inc. 60672feb-141f-651e-e053-2a91aa0af41d 2025-12-10 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