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 115 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c0400b-8ad9-654b-e063-6294a90ad040	2025-12-16		Exact identifier application number: M020
Non Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c00301-ee41-333c-e063-6294a90a61d5	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c078fa-05f9-ad80-e063-6394a90af3bb	2025-12-16		Exact identifier application number: M020
20Percent Zinc Oxide Non Tinted	ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c108f6-a928-0a54-e063-6394a90ae686	2025-12-16		Exact identifier application number: M020
20Percent Zinc Oxide Non Tinted	ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c0ccca-c993-181e-e063-6294a90a7ae6	2025-12-16		Exact identifier application number: M020
Non Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c0a55d-16d3-086a-e063-6394a90a30cf	2025-12-16		Exact identifier application number: M020
Eucerin Radiant Tone	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	2611e0cb-d56d-6ea1-e063-6294a90a745b	2025-12-16	Warnings	Exact identifier application number: M020
Really Great Lip Shield	TITANIUM DIOXIDE, ZINC OXIDE	JEFFREY J. ROTH, M.D., A PROFESSIONAL CORPORATION	36c1341d-fbf5-56a5-e063-6294a90aa045	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sunscreen	ZINC OXIDE	KLOE SALON LLC	36c23c07-2011-3ddb-e063-6294a90a76e9	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sun Defense	TITANIUM DIOXIDE, ZINC OXIDE	Helen's Haven	36c465ea-979b-9474-e063-6394a90ab3f8	2025-12-16		Exact identifier application number: M020
Mineral Lip Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	Helen's Haven	36c4a27b-96e9-4f30-e063-6294a90a5655	2025-12-16		Exact identifier application number: M020
Mineral Sunscreen Non Tinted	TITANIUM DIOXIDE, ZINC OXIDE	SAN JOSE MEDICAL SPA	37ef19e5-1775-a8d5-e063-6394a90acaef	2025-12-16		Exact identifier application number: M020
Tinted Mineral Sunscreen	ZINC OXIDE, TITANIUM DIOXIDE	BABYFACE LLC	36d69eb5-59b4-14a0-e063-6394a90a0a49	2025-12-16		Exact identifier application number: M020
Non Tinted Mineral Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	BABYFACE LLC	36d6141c-6967-d779-e063-6294a90af0a7	2025-12-16		Exact identifier application number: M020
Replenishing Daily Sunscreen	ZINC OXIDE	BABYFACE LLC	36d773d7-349d-68c1-e063-6394a90aff1e	2025-12-16		Exact identifier application number: M020
TiZO Tinted Moisturizing Serum - Light	ZINC OXIDE	Fallien Cosmeceuticals, Ltd.	2d44158a-44b3-5a3d-e063-6294a90a1f16	2025-12-16	Warnings	Exact identifier application number: M020
TiZO Tinted Moisturizing Serum - Light-Medium	ZINC OXIDE	Fallien Cosmeceuticals, Ltd.	2d53071f-0275-d00c-e063-6294a90afcca	2025-12-16	Warnings	Exact identifier application number: M020
TiZO Tinted Moisturizing Serum - Medium	ZINC OXIDE	Fallien Cosmeceuticals, Ltd.	2d550967-25af-3e7a-e063-6394a90a2c79	2025-12-16	Warnings	Exact identifier application number: M020
TiZO Tinted Moisturizing Serum - Medium-Deep	ZINC OXIDE	Fallien Cosmeceuticals, Ltd.	2d57790c-22cf-08aa-e063-6394a90aeac0	2025-12-16	Warnings	Exact identifier application number: M020
TiZO Tinted Moisturizing Serum - Deep	ZINC OXIDE	Fallien Cosmeceuticals, Ltd.	2d5813e8-a219-db90-e063-6294a90a6ca7	2025-12-16	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