Home NDC 82046-992 LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50
Product NDC 82046-992
11-digit product format 820460992
Labeler code 82046
Product ID 82046-992_dbe82016-deec-4bed-a41d-11f1a873728f
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 2024-04-01
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 2027-12-31
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 Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50
Listing expiration 2027-12-31 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 82046-992-01 LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50 40 mL in 1 TUBE CREAM 40 2 82046-992-01 LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50 1 in 1 CARTON CREAM 1 2 82046-992-02 LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50 5 mL in 1 TUBE CREAM 5 2 82046-992-02 LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50 15 in 1 CARTON CREAM 15 2
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 87 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dr Loretta Universal Glow Daily Defense SPF 40 ZINC OXIDE Dr. Loretta, LLC 1208d0f8-bb12-4574-b70e-3a76b11a64c7 2026-01-07 Warnings Exact identifier application number: M020 Neutrogena Ultra Sheer Face Sunscreen SPF 60 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE KDC/One Development Corporation, Inc. 259f3fe3-2967-6c05-e063-6394a90a9e45 2026-01-07 Warnings Exact identifier application number: M020 Hawaiian Blend Extreme Zinc SPF 30 ZINC OXIDE, TITANIUM DIOXIDE The Islander Group 4084dd98-357f-4011-b0d4-db6536d2931f 2026-01-07 Warnings Exact identifier application number: M020 Hawaiian Blend Extreme Zinc SPF 50 ZINC OXIDE, TITANIUM DIOXIDE The Islander Group 9b4acc5e-fdaf-4fcb-83a9-69e430dd43de 2026-01-07 Warnings Exact identifier application number: M020 Hawaiian Blend Sensitive Zinc SPF 50 ZINC OXIDE, TITANIUM DIOXIDE The Islander Group b42261c5-fa6e-4bb3-93c0-97032ab9f716 2026-01-07 Warnings Exact identifier application number: M020 CabanaMilk Mineral Barrier Fluid SPF 50 ZINC OXIDE NAKED SUNDAYS PTY LTD 47d0fe4d-ad21-1004-e063-6394a90a9c19 2026-01-07 Warnings Exact identifier application number: M020 CENTELLA RELIEF SOOTHING SUNSCREEN AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE IUNIK Co., Ltd. 47d170e3-dd76-d413-e063-6294a90ae8e4 2026-01-07 Warnings Exact identifier application number: M020 Round Lab Birch Juice Mild-Up UVLOCK Sunscreen SPF50 Broad Spectrum ZINC OXIDE SEORIN COMPANY Co., Ltd. 1e7cc417-3c57-c87c-e063-6394a90a670b 2026-01-07 Warnings Exact identifier application number: M020 Proactiv Clear Skin SPF 30 AVOBENZONE, OCTISALATE, AND OCTOCRYLENE Alchemee, LLC b0aa7ff0-f712-486f-aaaf-f88fed3b5cd1 2026-01-07 Warnings Exact identifier application number: M020 Daily Hydrating Mineral Body Sunscreen Broad Spectrum SPF 30 Sunscreen ZINC OXIDE Oak Essentials, LLC 47d37f44-10b2-214f-e063-6294a90a5abc 2026-01-07 Warnings Exact identifier application number: M020 PLUMSCREEN SPF 31 ZINC OXIDE Le Prunier Farms, Inc. e20eb996-2b64-6bd0-e053-2a95a90a4f92 2026-01-07 Warnings Exact identifier application number: M020 BETA-GLUCAN MILD SUNSCREEN TITANIUM DIOXIDE, ZINC OXIDE IUNIK Co., Ltd 47d6ad8b-1081-ee21-e063-6294a90a0e63 2026-01-07 Warnings Exact identifier application number: M020 Koobarra Mineral Face Sunscreen SPF 50 ZINC OXIDE SUNSCREEN VEGANIC SKN LIMITED 37cf8143-99f2-cca5-e063-6394a90a19a8 2026-01-07 Warnings Exact identifier application number: M020 Solar Swipe Mineral Sunscreen SPF50 SOLAR SWIPE MINERAL SUNSCREEN SPF50 Guangzhou Fantesy Biotechnology Co.,Ltd 47d75d61-5295-3eab-e063-6394a90a01c1 2026-01-07 Warnings Exact identifier application number: M020 LUXURY SUN RITUAL PORE SMOOTHING SPF 30 SUNSCREEN ZINC OXIDE JANE STREET LLC dbdd3e6a-f09d-90cf-e053-2a95a90a98a0 2026-01-07 Warnings Exact identifier application number: M020 RENEWALUXE SPF 50 Sunscreen RENEWALUXE SPF 50 SUNSCREEN Guangzhou Fantesy Biotechnology Co.,Ltd 1bc29960-5e73-e8ab-e063-6294a90a3f80 2026-01-06 Warnings Exact identifier application number: M020 ULTRA VIOLETTE VELVET SCREEN BLURRING MINERAL SKINSCREEN SPF50 Wild Child Laboratories PTY Ltd 2767ba3e-7434-d474-e063-6294a90aa4ff 2026-01-06 Warnings Exact identifier application number: M020 ULTRA VIOLETTE SPF ON THE GLOW Duo Pack Kit SPF 50 Grace And Fire USA Inc. 47b7da8a-ea89-1402-e063-6294a90a23f9 2026-01-06 Warnings Exact identifier application number: M020 Hawaiian Blend Essential Zinc SPF 30 ZINC OXIDE, TITANIUM DIOXIDE The Islander Group 5a6e622f-2c00-406a-8860-d7081656f597 2026-01-06 Warnings Exact identifier application number: M020 SHISEIDO SYNCHRO SKIN LASTING Liquid FOUNDATION Neutral 5 OCTINOXATE AND TITANIUM DIOXIDE SHISEIDO AMERICAS CORPORATION 66c22f17-5418-42ff-97b2-33fa10f5eac3 2026-01-06 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 82046-992-01 82046099201 1 TUBE in 1 CARTON (82046-992-01) / 40 mL in 1 TUBE 1 tube 2024-04-01 No No Current 82046-992-02 82046099202 15 TUBE in 1 CARTON (82046-992-02) / 5 mL in 1 TUBE 15 tube 2026-05-14 No No Current