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 316 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Boscia B.B. LIGHT Broad Spectrum SPF 27 PA Self-Adjusting Shade TITANIUM DIOXIDE, ZINC OXIDE Boscia LLC 5169b10e-5a8d-479a-a6a8-1e7a13cb70c4 2023-12-12 Warnings Exact identifier application number: M020 Boscia All In One B.B. Eye Brightener Broad Spectrum SPF 20 TITANIUM DIOXIDE Boscia LLC f76166f1-e987-4eaf-8192-14dc08c481f7 2023-12-12 Warnings Exact identifier application number: M020 Boscia Daily Defense Sunscreen Broad Spectrum SPF 50 PA OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE Boscia LLC 2a6b507f-0967-46e1-8360-0003772f1bdb 2023-12-12 Warnings Exact identifier application number: M020 Likewise Facial Moisturizer - Sun Protectant SPF 50 Normal to Oily Skin OCTINOXATE, OCTISALATE, ZINC OXIDE Likewise Incorporated 97bd2033-2cf0-4e5d-81e2-c453a1e3a65e 2023-12-12 Warnings Exact identifier application number: M020 3LAB Aqua BB SPF 40 BROAD SPECTRUM 01 TITANIUM DIOXIDE 3LAB, Inc. 703dc828-24b4-4f04-9f2c-4a2edfdf4632 2023-12-12 Warnings Exact identifier application number: M020 3LAB Aqua BB SPF 40 BROAD SPECTRUM 02 TITANIUM DIOXIDE 3LAB, Inc. 7c6c7062-91f7-4304-98c3-f77967a2d329 2023-12-12 Warnings Exact identifier application number: M020 Likewise Facial Moisturizer - Sun Protectant SPF 50 Normal to Dry Skin OCTINOXATE, OCTISALATE, ZINC OXIDE Likewise Incorporated 8a75dde9-8dcb-4f4a-b9df-88338bd2a440 2023-12-12 Warnings Exact identifier application number: M020 Everyday Facial Moisturizer And Sunscreen SPF 20 ZINC OXIDE 714 Essentials LTD 3a29018b-8103-4983-b0c5-5f340775a05d 2023-12-12 Warnings Exact identifier application number: M020 Likewise Hand Moisturizer - Sun Protectant SPF 50 OCTINOXATE, OCTISALATE, ZINC OXIDE Likewise Incorporated a54f0854-c55e-4a46-9084-16cb1be0f681 2023-12-12 Warnings Exact identifier application number: M020 3LAB PERFECT BB SPF 40 Broad Spectrum 01 TITANIUM DIOXIDE 3LAB, Inc bd39d2fb-8326-4e19-b634-7a7308313d8a 2023-12-12 Warnings Exact identifier application number: M020 3LAB PERFECT BB SPF 40 Broad Spectrum 03 TITANIUM DIOXIDE 3LAB, Inc 19884289-edb2-4d18-bd62-873533b94a10 2023-12-12 Warnings Exact identifier application number: M020 Bass Pro Shops Mineral Sun Stick Sunscreen Broad Spec SPF 40 TITANIUM DIOXIDE, ZINC OXIDE ENGLEWOOD LAB, INC. 92dc1a86-590e-4144-9d30-172645e63140 2023-12-12 Warnings Exact identifier application number: M020 3LAB PERFECT BB SPF 40 Broad Spectrum 02 TITANIUM DIOXIDE 3LAB, Inc bf4419b9-408d-469a-aa15-bbf419632f02 2023-12-12 Warnings Exact identifier application number: M020 3LAB PERFECT Sunscreen SPF 50 Plus Broad Spectrum HOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE 3LAB, Inc 2bee6b87-c889-4ea1-87ad-e28949bcb67a 2023-12-12 Warnings Exact identifier application number: M020 Likewise Facial Moisturizer - Sun Protectant SPF 50 Oily Skin TITANIUM DIOXIDE, ZINC OXIDE Likewise Incorporated 28b8c519-8417-427e-8d4f-94da44a69d9f 2023-12-12 Warnings Exact identifier application number: M020 BEET THE SUN LIGHTWEIGHT SUNSCREEN BROAD SPECTRUM SPF 40 PA AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE ENGLEWOOD LAB, INC. f5c795f0-63bc-3033-e053-2995a90a55ab 2023-12-12 Warnings Exact identifier application number: M020 Bass Pro Shops Bass P Sunscreen Broad Spectrum SPF 50 TITANIUM DIOXIDE, ZINC OXIDE ENGLEWOOD LAB, INC. c06ecc56-2044-4396-8acd-6d18af9b984c 2023-12-12 Warnings Exact identifier application number: M020 SUMMARY EVERYDAY MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 TITANIUM DIOXIDE, ZINC OXIDE ENGLEWOOD LAB, INC. f5c7b7ce-b3ed-3e96-e053-2995a90a8ea9 2023-12-12 Warnings Exact identifier application number: M020 Milani SPF BFF 30 Primer AVOBENZONE, OCTINOXATE, OCTOCRYLENE, OXYBENZONE New Milani Group, LLC c7a1f2a7-d299-2116-e053-2995a90ad8c5 2023-12-12 Warnings Exact identifier application number: M020 MILANI MAKE IT LAST SUNSCREEN SETTING SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE New Milani Group, LLC 8f52f614-1cfe-4ef0-8cb6-37afbfddf44c 2023-12-12 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