Home NDC 49967-199 LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Broad Spectrum SPF 50 Sunscreen Skin Protectant
Product NDC 49967-199
11-digit product format 499670199
Labeler code 49967
Product ID 49967-199_b2f0c42f-aea9-413f-8d08-da5bcec7dfc7
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 2024-06-01
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 2026-12-31
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 Broad Spectrum SPF 50 Sunscreen Skin Protectant
Listing expiration 2026-12-31 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 49967-199-01 LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Broad Spectrum SPF 50 Sunscreen Skin Protectant 1 in 1 CARTON CREAM 1 1 49967-199-01 LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Broad Spectrum SPF 50 Sunscreen Skin Protectant 40 mL in 1 TUBE CREAM 40 1 49967-199-02 LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Broad Spectrum SPF 50 Sunscreen Skin Protectant 20 in 1 PACKAGE CREAM 20 1 49967-199-02 LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Broad Spectrum SPF 50 Sunscreen Skin Protectant 5 mL in 1 TUBE CREAM 5 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49967-199 LA ROCHE POSAY LABORATOIRE DERMATOLOGIQUE CICAPLAST BALM B5 UV BROAD SPECTRUM SPF 50 SUNSCREEN SKIN PROTECTANT (DIMETHICONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDE) CREAM [L’OREAL USA PRODUCTS INC] 1 Current NDC, 4 package rows 20241225_e8539a43-db85-451c-bce8-2c488f3dc40d.zip
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 181 of 353 · 7,041 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Essential Defense Mineral Shield Broad Spectrum SPF 35 Sunscreen TITANIUM DIOXIDE AND ZINC OXIDE Allergan, Inc. 29817fdc-f14c-4013-a8ed-4367f3b2867c 2025-10-09 Warnings Exact identifier application number: M020 Skinny Dip SPF-50 ZINC OXIDE Cove Suncare LLC 7bef2966-9351-4ea6-aeed-0d568376d86b 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Broad Spectrum SPF 60 Plus AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 0f0ba2e9-126f-13c0-e063-6394a90aa6a4 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 08997bd4-d6b9-fffc-e063-6294a90a77ae 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Beach Defense Water Plus Sun Protection Sunscreen Broad Spectrum SPF70 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE Kenvue Brands LLC 75f81b2d-cabc-443f-b4b5-76bd2321826b 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Sunscreen Broad Spectrum SPF 60 Plus AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 1390f863-709e-412b-9a25-b65217844e44 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Sunscreen Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC ccc2e40b-5301-4055-8a89-47366687cfb7 2025-10-08 Warnings Exact identifier application number: M020 Neutrogena Invisible Daily Defense Broad Spectrum SPF 30 AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE Kenvue Brands LLC 0f0dd2e4-3dda-c872-e063-6294a90a20a3 2025-10-08 Warnings Exact identifier application number: M020 ScalpHair MistSunscreen SPF30 COOLA SCALPHAIR MIST ORGANIC SUNSCREEN SPF30 COOLA LLC c7d2098f-6fdf-68e5-e053-2a95a90a1898 2025-10-08 Warnings Exact identifier application number: M020 Block Party SPF-50 ZINC OXIDE Cove Suncare LLC 24ffb6ec-d922-40c0-b325-c15f8433027a 2025-10-08 Warnings Exact identifier application number: M020 Sun Kids mineral BLUEBERRY SUNSCREEN BROAD SPECTRUM SPF 50 ZINC OXIDE The Natural SKN Company 40945805-6f2e-74a1-e063-6394a90a04a3 2025-10-07 Warnings Exact identifier application number: M020 ProtecTINT 10N HOMOSALATE, OCTISALATE, ZINC OXIDE Supergoop, LLC 0801287f-0df5-4303-e063-6394a90a503b 2025-10-07 Warnings Exact identifier application number: M020 Vertra Pearl White Face Stick SPF 50 PADIMATE O, TITANIUM DIOXIDE Eai-jr 286, Inc b69a75e0-8724-35ae-e053-2a95a90a5f34 2025-10-07 Warnings Exact identifier application number: M020 Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta Beige TITANIUM DIOXIDE EAI-JR 286, Inc. b9ea12e8-6ed9-d805-e053-2a95a90aa107 2025-10-07 Warnings Exact identifier application number: M020 SPF50 Sunscreen SUNSCREEN KINGKEY MBC LIFE TECHNOLOGY GROUP CO., LTD b3cde609-7d62-2ac7-e053-2a95a90a26b3 2025-10-07 Exact identifier application number: M020 Summer Face Sunscreen SPF 50 AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE SUMMER GELEE LLC fe256ff4-cb92-4262-8ab9-7cc912e0af22 2025-10-06 Warnings Exact identifier application number: M020 Sun Veil Broad Spectrum SPF50 ZINC OXIDE MONAT GLOBAL CORP 3ba28de7-74a2-5cde-e063-6394a90add26 2025-10-06 Warnings Exact identifier application number: M020 Vertra Mick Fanning Signature Foundation Sunscreen Face Stick SPF 35 Coolangatta Beige TITANIUM DIOXIDE Toshiki Pigment Co., Ltd. b9eba15f-493a-43c9-e053-2995a90a0451 2025-10-06 Warnings Exact identifier application number: M020 Apple Lip Balm with Aloe Vera BROAD SPECTRUM SPF 15 SUNSCREEN LIP BALM Durvet, Inc. 6dcbb2cd-e690-4970-8cf1-08ca539d3602 2025-10-06 Warnings Exact identifier application number: M020 PURE SOL SPF 50 Daily Moisturizer ZINC OXIDE Brand 2022b LLC 4051506c-fc13-cd22-e063-6394a90a977e 2025-10-04 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 49967-199-01 49967019901 1 TUBE in 1 CARTON (49967-199-01) / 40 mL in 1 TUBE 1 tube 2024-06-01 No No Current 49967-199-02 49967019902 20 TUBE in 1 PACKAGE (49967-199-02) / 5 mL in 1 TUBE 20 tube 2024-06-01 No No Current