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 185 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
ELROEL Pang Pang Sun Cushion Plus	ZINC OXIDE, TITANIUM DIOXIDE, OCTINOXATE, OCTISALATE	MONOGLOT HOLDINGS Inc.	5ffaad65-f0b2-416a-b0a3-b92e880641e4	2025-09-18	Warnings	Exact identifier application number: M020
e.l.f. Camo CC Cream SPF 30 Fair 125 C	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	e.l.f. Cosmetics, Inc.	407f9c0d-31c6-f5bb-e063-6394a90a4db4	2025-09-18	Warnings	Exact identifier application number: M020
Neutrogena Collagen Bank SPF Moisturizer Sunscreen Broad Spectrum SPF 30	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Kenvue Brands LLC	1630feee-7e0d-c6f4-e063-6294a90a7b1c	2025-09-17	Warnings	Exact identifier application number: M020
Guise Tinted Drops	ZINC OXIDE	Donis Men LLC	3f039049-5004-2888-e063-6294a90a5150	2025-09-17	Warnings	Exact identifier application number: M020
ONE SIZE ON TIL DAWN	ONE SIZE ON TIL DAWN	Pogi Beauty LLC	3f05d90b-9274-4d21-e063-6294a90a8485	2025-09-17	Warnings	Exact identifier application number: M020
PUR 4-in-1 Skin Tint DP3	ZINC OXIDE	PUR Minerals	3f073413-b314-e5da-e063-6394a90a9ab4	2025-09-17	Warnings	Exact identifier application number: M020
e.l.f. Hydrating Camo CC Cream SPF30 Fair 100 W	HOMOSALATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE	e.l.f. Cosmetics, Inc.	3fa7ef54-2c4d-9883-e063-6294a90a8d88	2025-09-17	Warnings	Exact identifier application number: M020
CVS SPF 50 Face Sunscreen	TITANIUM DIOXIDE, ZINC OXIDE	CVS	26a69a47-947a-a478-e063-6394a90aa468	2025-09-16	Warnings	Exact identifier application number: M020
SkinSuit TM 3 in 1 Moisturizer SPF 50	ZINC OXIDE	Skin Authority LLC	5eb27be9-9e80-4f4a-b193-b918d831555d	2025-09-15	Warnings	Exact identifier application number: M020
Sun and Honey Tallow Sunscreen SPF 30	ZINC OXIDE	Amara Ventures	3eda8a70-7c9e-e920-e063-6394a90a85a2	2025-09-15	Warnings	Exact identifier application number: M020
Klein Tools Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	KLEIN TOOLS, INC.	3edcc26a-d960-3fa8-e063-6394a90ab703	2025-09-15	Warnings	Exact identifier application number: M020
Klein Tools Sunscreen SPF 50	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	KLEIN TOOLS, INC.	3ede5e54-4c9f-02f7-e063-6294a90a9df6	2025-09-15	Warnings	Exact identifier application number: M020
I.C. Industrial Sunscreen	ZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATE	R & R Lotion, Inc	b89d687a-7b36-4643-9817-765d4710ca60	2025-09-15	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	Kenvue Brands LLC	97795f0e-d867-4e17-b7c9-ede08e7df70c	2025-09-12	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 36N Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	2d05659c-57d2-4faf-ab67-1b8d68945aed	2025-09-12	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 37W Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	5ff2b9e4-a778-4667-8c3c-3561317b374a	2025-09-12	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 39N Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	bc4f909f-3e2c-4fd7-a129-3c2fac8259f0	2025-09-12	Warnings	Exact identifier application number: M020
Dolce and Gabbana Blueberry Nutri Tint SPF 20 40C Deep	ZINC OXIDE	DOLCE & GABBANA BEAUTY S.R.L.	2dd9a30a-2cde-44c0-9350-3aeab9f7091b	2025-09-12	Warnings	Exact identifier application number: M020
Dolce and Gabbana Get Your Healthy Glowy Skin Bergamot Glow Primer Blueberry Nutri Tint	ZINC OXIDE	Dolce & Gabbana Beauty S.R.L	e375412e-8685-49a2-b1b0-00ab114e14b7	2025-09-12	Warnings	Exact identifier application number: M020
Beach Club Mineral Sunscreen	ZINC OXIDE, OCTINOXATE, OXYBENZONE, AND OCTISALATE	R & R Lotion, Inc	d9aae241-229e-4123-abe9-99f74f5ab0b3	2025-09-12	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