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 328 of 346 · 6,912 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Dr. C. Tuna Resurface Essential Day Cream HOMOSALATE, OCTINOXATE, OCTOCRYLENE, AVOBENZONE Farmasi US LLC b92ff1e9-9dc4-46cb-a99d-98ff15bffc79 2023-11-05 Warnings Exact identifier application number: M020 Dr C Tuna Sun protector lip balm SPF 15 HOMOSALATE, OCTINOXATE Farmasi US LLC ddcd82b5-9ad2-2340-e053-2a95a90a4fc0 2023-11-05 Warnings Exact identifier application number: M020 Farmasi BB Beauty Balm Cream SPF 15- 04 Medium to Tan TITANIUM DIOXIDE Farmasi US LLC deee5784-c68b-4cd7-acbf-f64391a01bfc 2023-11-05 Warnings Exact identifier application number: M020 Farmasi BB Beauty Balm Cream SPF 15- 02 Light to Medium TITANIUM DIOXIDE Farmasi US LLC cef1a926-b7d4-47d6-957d-e3092e60970c 2023-11-05 Warnings Exact identifier application number: M020 Dr. C. Tuna Lumi Radiance Brightening Cream OCTOCRYLENE, OCTINOXATE, AVOBENZONE Farmasi US LLC b55790f7-20f2-404e-9a0e-5e76c383bf75 2023-11-05 Warnings Exact identifier application number: M020 Dr. C. Tuna Lumi Radiance Brightening Cream 22 SPF OCTOCRYLENE, OCTINOXATE, AVOBENZONE Farmasi US LLC de493e30-d10e-9def-e053-2995a90ae49a 2023-11-05 Warnings Exact identifier application number: M020 Dr. C. Tuna Sun Face and Body SPF 50 AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE Farmasi US LLC 141f9d22-deb7-4b6b-97b5-ee21898b96f7 2023-11-05 Warnings Exact identifier application number: M020 Farmasi BB Beauty Balm Cream SPF 15- 06 Deep TITANIUM DIOXIDE Farmasi US LLC 2f13a160-740f-4b09-8858-e438a9ba303e 2023-11-05 Warnings Exact identifier application number: M020 Dr. C. Tuna Sun Bronzing Oil SPF 6 OCTINOXATE Farmasi US LLC 91b428cc-1c80-4d56-8450-790c66de4133 2023-11-05 Warnings Exact identifier application number: M020 Farmasi BB Beauty Balm Cream SPF 15- 05 Tan TITANIUM DIOXIDE Farmasi US LLC 3f494921-844e-4010-ab0c-144c8dce8aca 2023-11-05 Warnings Exact identifier application number: M020 Farmasi CC Color Control Cream SPF 25 TITANIUM DIOXIDE Farmasi US LLC f4fcfc78-9591-4a20-b9fb-88e1dc9b221d 2023-11-05 Warnings Exact identifier application number: M020 Farmasi CC Color Control Cream SPF 25- 02 Light to Medium TITANIUM DIOXIDE Farmasi US LLC 0d913242-2e57-4ba7-a718-154af68480b2 2023-11-05 Warnings Exact identifier application number: M020 Farmasi BB Beauty Balm Cream SPF 15- 03 Medium TITANIUM DIOXIDE Farmasi US LLC 6ef986df-4044-4c32-8b64-f8110c9c9543 2023-11-05 Warnings Exact identifier application number: M020 Farmasi CC Color Control Cream SPF 25- 04 Medium to Tan TITANIUM DIOXIDE Farmasi US LLC de24317f-2cf0-4125-bb17-c3d6b3c22e00 2023-11-05 Warnings Exact identifier application number: M020 Farmasi CC Color Control Cream SPF 25- 05 Tan TITANIUM DIOXIDE Farmasi US LLC 22842793-ae1f-4b71-8db9-34c06dc37daa 2023-11-05 Warnings Exact identifier application number: M020 Farmasi CC Color Control Cream SPF 25- 03 Medium TITANIUM DIOXIDE Farmasi US LLC 9f203e7f-3bba-4f36-a35a-6d9466e39082 2023-11-05 Warnings Exact identifier application number: M020 Farmasi CC Color Control Cream SPF 25- 06 Deep TITANIUM DIOXIDE Farmasi US LLC c28afa3b-9a8d-4e19-bc6b-39cc8428c9f9 2023-11-05 Warnings Exact identifier application number: M020 DR. C Tuna Sunscreen 30 SPF Broad Spectrum Face and body AVOBENZONE, OCTINOXATE, OCTOCRYLENE, HOMOSALATE TAN-ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETI a71ee8e0-2d27-7ae6-e053-2a95a90aecd4 2023-11-05 Warnings Exact identifier application number: M020 PHARMACA Natural Mineral Sunscreen SPF-50 TITANIUM DIOXIDE, ZINC OXIDE Pharmaca Integrative Pharmacy, Inc. 51e6cd7a-5c9a-4666-9021-ade42eb064cd 2023-11-05 Warnings Exact identifier application number: M020 Dr.C.Tuna Sun Face Cream SPF50 AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENE Tan Alize Kozmetik ve Temizlik Urunleri Sanayi ve Ticaret Anonim Sirketi f668c078-61e6-2c81-e053-2a95a90a3100 2023-11-05 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