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 147 of 357 · 7,139 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join MATTE SHIELD SPF ZINC OXIDE ACNE SOLUTIONS NYC INC 2fb00db0-4c37-56c6-e063-6294a90a8aff 2025-12-08 Warnings Exact identifier application number: M020 Matte Shield SPF TITANIUM DIOXIDE, ZINC OXIDE ACNE SOLUTIONS NYC INC 3bb582ec-71e7-4ad8-e063-6394a90a94d4 2025-12-08 Warnings Exact identifier application number: M020 SPF 101 Lightly Tinted ZINC OXIDE The Acne Lab LLC 334afdc8-1e12-d787-e063-6294a90aed7c 2025-12-08 Exact identifier application number: M020 SPF 101 Non-Tinted ZINC OXIDE The Acne Lab LLC 334bf8ea-2485-84e8-e063-6294a90aefa6 2025-12-08 Exact identifier application number: M020 SPF 101 Lightly Tinted ZINC OXIDE The Acne Lab LLC 334d694a-f9e4-ae86-e063-6394a90abfe1 2025-12-08 Exact identifier application number: M020 SPF 101 Non-Tinted ZINC OXIDE The Acne Lab LLC 334e32a4-c3a5-e37d-e063-6294a90ad6cf 2025-12-08 Exact identifier application number: M020 Mineral Based Sunscreen Stick Non-Tinted TITANIUM DIOXIDE, ZINC OXIDE KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION 3245561d-a90c-7bf0-e063-6394a90ab3b6 2025-12-08 Exact identifier application number: M020 Mineral Based Sunscreen Stick Tinted TITANIUM DIOXIDE, ZINC OXIDE KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION 3245c1f7-2c1b-b6ad-e063-6394a90aaee6 2025-12-08 Exact identifier application number: M020 Mineral Based Facial Sunscreen ZINC OXIDE KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION 3e8981ed-5847-7009-e063-6394a90a49a1 2025-12-08 Warnings Exact identifier application number: M020 Replenishing Daily Protection Sunscreen Invisible ZINC OXIDE KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION 32462e88-0e74-a675-e063-6294a90ac564 2025-12-08 Exact identifier application number: M020 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
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