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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
V06SV4M95S	Internal UNII lookup
4X49Y0596W	Internal UNII lookup
92RU3N3Y1O	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
e8539a43-db85-451c-bce8-2c488f3dc40d	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	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&RSQUO;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 190 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sun Bum 30 Mineral Sunscreen Lip Balm	ZINC OXIDE	Sun Bum, LLC	3cbfba65-5702-50b5-e063-6394a90a409d	2025-08-19	Warnings	Exact identifier application number: M020
Sun Bum Signature High Performance Mineral Sunscreen Face Stick Tinted 50	ZINC OXIDE	Sun Bum, LLC	324e8ddb-89d2-08ca-e063-6294a90ab6c1	2025-08-19	Warnings	Exact identifier application number: M020
Sun Bum 70 Premium Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3b02811d-dc66-fc6f-e063-6294a90aefc8	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Kids 50 Clear Sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3b058b74-27d0-8f8a-e063-6294a90aa02c	2025-08-18	Warnings	Exact identifier application number: M020
PLAY Mineral Stick SPF 50 with Olive Fruit Extract	ZINC OXIDE	Supergoop LLC	3ca7e1ed-7cc7-76b0-e063-6394a90ade93	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Mineral 30 Sunscreen 6 OZ	ZINC OXIDE	Sun Bum, LLC	3b91a7e3-ce52-6aa0-e063-6394a90a15e7	2025-08-18	Warnings	Exact identifier application number: M020
CoTZ Kids	ZINC OXIDE	Fallien Cosmeceuticals, LTD.	3ca8742f-67cb-a25c-e063-6394a90a4638	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum 30 Premium Moisturizing Sunscreen 8 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3b154009-9c6f-eadf-e063-6394a90ae424	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Kids 50 Clear Sunscreen 6 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3b162348-0222-490e-e063-6394a90ad494	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum 50 Premium Moisturizing Sunscreen 1.75 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3b169860-66bc-dd02-e063-6294a90a7974	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum 30 Mineral Sunscreen Face 1.7 OZ	TITANIUM DIOXIDE, ZINC OXIDE	Sun Bum, LLC	3b1729c5-d8ca-94c7-e063-6394a90a67a5	2025-08-18	Warnings	Exact identifier application number: M020
CoTZ Kids	ZINC OXIDE	Fallien Cosmeceuticals, LTD.	3ca914e2-cd53-42bf-e063-6294a90a7082	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Daily Mineral Sunscreen Moisturizer Broad Spectrum SPF 30	ZINC OXIDE	Sun Bum, LLC	3b1a0596-b852-16be-e063-6394a90a3498	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Signature Clear High Performance Sunscreen Broad Spectrum SPF 50 1.5 OZ	OCTISALATE, OCTOCRYLENE, ZINC OXIDE	Sun Bum, LLC	3b29dbfc-0b92-eb0f-e063-6294a90a16e1	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum 30 Mineral Sunscreen 32 OZ	ZINC OXIDE	Sun Bum, LLC	3b2cb7cf-7e2c-0fd2-e063-6294a90a3b17	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Sunscreen Oil 50 5 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3b2b4ba0-3f89-0a04-e063-6294a90ac1c0	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Signature Sunscreen Premium Zinc Lip Balm Broad Spectrum SPF 30	ZINC OXIDE	Sun Bum, LLC	3ca9e9d3-1c73-7bd6-e063-6394a90ad204	2025-08-18	Warnings	Exact identifier application number: M020
Ocean Potion Suncare Mineral 50 Essential Scent of Sunshine Zinc Oxide Continuous Sunscreen	ZINC OXIDE	GNL BRANDS INTERNATIONAL, LLC	3caaea85-0dfe-6f69-e063-6294a90a7d4a	2025-08-18	Warnings	Exact identifier application number: M020
PLAY Lip Shield SPF 30 - Mint	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Supergoop LLC	3cab1a7d-6226-9eba-e063-6294a90a8c4d	2025-08-18	Warnings	Exact identifier application number: M020
Sun Bum Broad Spectrum SPF 30 5 OZ	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Sun Bum, LLC	3cad0757-3155-c716-e063-6294a90ad7a9	2025-08-18	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

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

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Drug Facts	L’Oreal USA Products Inc \| L'OREAL USA PRODUCTS, INC.	2024-12-23	HUMAN OTC DRUG LABEL	1