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 257 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join CLE CCC Neutral Medium Light TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE KW ABSC, INC. 615f5e39-695d-41d4-af59-e0d3b76789bb 2024-12-19 Warnings Exact identifier application number: M020 CLE CCC Warm Deep TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, AVOBENZONE KW ABSC, INC. 6ab3e360-8104-4439-93fb-e11bc4a77558 2024-12-19 Warnings Exact identifier application number: M020 CLE CCC Neutral Medium TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE KW ABSC, INC. a297ff64-678c-4936-8384-022606a2f33c 2024-12-19 Warnings Exact identifier application number: M020 CLE CCC Neutral Fair TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE KW ABSC, INC. aa8176c6-f1c9-43dd-96e0-f7d6ed30a1a2 2024-12-19 Warnings Exact identifier application number: M020 CLE CCC Cool Medium Deep TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE KW ABSC, INC. 2e0365f9-d3c6-4404-90ac-772a829b3ade 2024-12-19 Warnings Exact identifier application number: M020 Light Illusion Luminous Makeup Nude-Skin Feel SPF18- D2 NUTMEG OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE COSMAX USA, INC 29abae8f-53db-b592-e063-6294a90adabb 2024-12-19 Warnings Exact identifier application number: M020 Light Illusion Luminous Makeup Nude-Skin Feel SPF18 MOCHA OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE COSMAX USA, INC 29aba80c-55b7-b8d9-e063-6294a90a5cc1 2024-12-19 Warnings Exact identifier application number: M020 Light Illusion Luminous Makeup Nude-Skin Feel SPF18 COCOA OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE COSMAX USA, INC 29abe97b-e9b3-6e27-e063-6294a90ae3ed 2024-12-19 Warnings Exact identifier application number: M020 Light Illusion Luminous Makeup Nude-Skin Feel SPF18 DEEP GOLDEN OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE COSMAX USA, INC 29abdf3c-fb54-a5e3-e063-6394a90af450 2024-12-19 Warnings Exact identifier application number: M020 MILK TINT SPF 43 TINTED PRIMER SERUM FAIR ZINC OXIDE COSMAX USA, CORPORATION 29ac756b-3df7-50c9-e063-6394a90aa479 2024-12-19 Warnings Exact identifier application number: M020 MILK TINT SPF 43 TINTED PRIMER SERUM RICH ZINC OXIDE COSMAX USA, CORPORATION 29ac51a0-07e7-ad7b-e063-6294a90ae777 2024-12-19 Warnings Exact identifier application number: M020 MILK TINT SPF 43 TINTED PRIMER SERUM DEEPEST ZINC OXIDE COSMAX USA, CORPORATION 29ad12e2-0a2e-7138-e063-6394a90aebaf 2024-12-19 Warnings Exact identifier application number: M020 CeraVe Developed with Dermatologists Hydrating Mineral Sunscreen Broad Spectrum SPF 30 Face Sheer Tint Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE L'Oreal USA Products, Inc. f2e34230-7bfb-455f-8b33-6bff96fd9f0a 2024-12-19 Warnings Exact identifier application number: M020 Anew Platinum DayCream Broad Spectrum SPF 25 AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE COSMAX USA, CORPORATION 56200212-bedc-6e1e-e063-6394a90a3666 2024-12-19 Warnings Exact identifier application number: M020 Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SHELL OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE COSMAX USA, INC 29868d60-b900-e0ad-e063-6294a90af87a 2024-12-18 Warnings Exact identifier application number: M020 MILK TINT SPF 43 TINTED PRIMER SERUM MEDIUM ZINC OXIDE COSMAX USA, CORPORATION 298707d4-72ed-796f-e063-6294a90aa5cd 2024-12-18 Warnings Exact identifier application number: M020 MILK TINT SPF 43 TINTED PRIMER SERUM LIGHT ZINC OXIDE COSMAX USA, CORPORATION 29871c02-9adf-6266-e063-6394a90a20ab 2024-12-18 Warnings Exact identifier application number: M020 MILK TINT SPF 43 TINTED PRIMER SERUM TAN ZINC OXIDE COSMAX USA, CORPORATION 29874029-24bf-b2ce-e063-6394a90acd4d 2024-12-18 Warnings Exact identifier application number: M020 Babo Botanicals Sheer Zinc Mineral Sunscreen SPF 30 ZINC OXIDE Babo Botanicals, Inc. 2990e4ff-5bdb-3008-e063-6294a90a9497 2024-12-18 Warnings Exact identifier application number: M020 Tinted Lip Cream SPF 15 ZINC OXIDE COSMAX USA, CORPORATION 29915354-4673-7444-e063-6294a90a0fd1 2024-12-18 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