FDA.reportPublic FDA data

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
IngredientStrength
HOMOSALATE80 mg/mL
OCTISALATE50 mg/mL
DIMETHICONE10 mg/mL
OCTOCRYLENE50 mg/mL
ZINC OXIDE70 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 5 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
4X49Y0596WInternal UNII lookup
92RU3N3Y1OInternal UNII lookup
5A68WGF6WMInternal UNII lookup
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
92a1d6ce-aff3-45fc-8d98-20c4375aded8Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82046-992-01LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 5040 mL in 1 TUBECREAM402
82046-992-01LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 501 in 1 CARTONCREAM12
82046-992-02LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 505 mL in 1 TUBECREAM52
82046-992-02LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 5015 in 1 CARTONCREAM152

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 136 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daily Protection 40ZINC OXIDE2301 PLASTIC SURGERY, PLLC374d9c77-ed9f-a518-e063-6394a90a34fa2025-12-11Exact identifier
application number: M020
Tinted Mineral 40TITANIUM DIOXIDE, ZINC OXIDE2301 PLASTIC SURGERY, PLLC374df66d-eb9b-c4a7-e063-6394a90a3cc62025-12-11Exact identifier
application number: M020
Daily Protection 40ZINC OXIDE2301 PLASTIC SURGERY, PLLC374e2294-7281-c7b9-e063-6394a90acc892025-12-11Exact identifier
application number: M020
Facial Mineral Sunscreen Mineral ProtectionTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.387f6dd5-3901-0849-e063-6294a90af8bc2025-12-11Exact identifier
application number: M020
Non - Tinted Mineral SunscreenZINC OXIDENEXTEX CORPORATION35bacfcf-0254-aa0a-e063-6394a90a14752025-12-11Exact identifier
application number: M020
Facial Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELEDUC, XUANTO MD387e2e59-c5db-c70e-e063-6394a90a2d262025-12-11Exact identifier
application number: M020
Facial Mineral Sunscreen Mineral ProtectionTITANIUM DIOXIDE, ZINC OXIDECAPE COD SKIN CARE CO. INC.390779a8-4556-27a5-e063-6294a90a12002025-12-11Exact identifier
application number: M020
non-tinted sheer matte mineralTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35ba6cc9-0d49-6d0c-e063-6394a90ac7c32025-12-11Exact identifier
application number: M020
sheer tinted matte mineralTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35ba9ca7-fe5c-9824-e063-6394a90a5c462025-12-11Exact identifier
application number: M020
illuminating mineral mousseTITANIUM DIOXIDE, ZINC OXIDENEXTEX CORPORATION35bb4d67-373f-f60c-e063-6394a90a974d2025-12-11Exact identifier
application number: M020
Soft Focus Mineral Defense TintedTITANIUM DIOXIDE, ZINC OXIDESPOTLESS SKIN STUDIO387f1ea9-4764-3abe-e063-6394a90adde02025-12-11Exact identifier
application number: M020
flawless photo finishZINC OXIDENEXTEX CORPORATION35bb0ac4-6abd-ca75-e063-6394a90a26cd2025-12-11Exact identifier
application number: M020
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352efbee-cab4-c515-e063-6294a90a46f22025-12-11Exact identifier
application number: M020
Daily Defense Tinted Mineral SunscreenTITANIUM DIOXIDE, ZINC OXIDELEDUC, XUANTO MD387e6e79-94db-dbb1-e063-6394a90aefd62025-12-11Exact identifier
application number: M020
Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352f5c53-3075-f437-e063-6394a90a4c4e2025-12-11Exact identifier
application number: M020
PreventionTITANIUM DIOXIDE, ZINC OXIDENoble Center for Healthy Aging LLC387dbf46-4316-a15d-e063-6394a90adeb12025-12-11Exact identifier
application number: M020
Gentle Defense SunscreenZINC OXIDEMint Skin Incroporated352fe5e4-8b3f-248f-e063-6394a90ab42c2025-12-11Exact identifier
application number: M020
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incorporated352f8de3-8ff0-4098-e063-6294a90ace4d2025-12-11Exact identifier
application number: M020
Tinted Matte Defense Sunscreen PrimerTITANIUM DIOXIDE, ZINC OXIDEMint Skin Incroporated35305bf1-8947-f275-e063-6294a90a30242025-12-11Exact identifier
application number: M020
Gentle Defense SunscreenZINC OXIDEMint Skin Incorporated3530898c-7bdf-6ffe-e063-6394a90aa0372025-12-11Exact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82046-992-01820460992011 TUBE in 1 CARTON (82046-992-01) / 40 mL in 1 TUBE1 tube2024-04-01NoNoCurrent
82046-992-028204609920215 TUBE in 1 CARTON (82046-992-02) / 5 mL in 1 TUBE15 tube2026-05-14NoNoCurrent