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 156 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ATTITUDE Sensitive natural Mineral Sunscreen Stick SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE4495a302-51b9-3bf2-e063-6294a90a7e4f2025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral sunscreen Sprayer SPF 50 Watermelon and cocoZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aa1349-e3f1-9b80-e063-6294a90a0fbd2025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral sunscreen SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aaa3c8-ccc4-ae93-e063-6394a90aedc52025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Baby Mineral sunscreen SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aba591-04da-fe09-e063-6394a90a912a2025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral sunscreen SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aba6d7-7989-0637-e063-6394a90a6c8f2025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral sunscreen SPF 50 Tropical cocoZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44abca13-8ba9-8925-e063-6294a90accb52025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sensitive natural baby Mineral sunscreen SPF 50 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44abdfe1-ea6b-a158-e063-6294a90a3eb82025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Kids Mineral sunscreen SPF 50 Watermelon and cocoZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aca1d5-6e0a-def3-e063-6294a90aca262025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral sunscreen SPF 50 Sun kissed vanillaZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aca181-2a90-20a6-e063-6394a90aff472025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Mineral sunscreen Sprayer SPF 50 Sun kissed vanillaZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44aa529b-2077-3660-e063-6394a90aa4052025-11-28WarningsExact identifier
application number: M020
ATTITUDE Sunly Lip Balm SPF 15 UnscentedZINC OXIDE9055-7588 Qubec Inc.DBA ATTITUDE44ad65f0-ec1d-1638-e063-6294a90a22442025-11-28WarningsExact identifier
application number: M020
HOEGOA Hair Scalp Sunscreen MineralTITANIUM DIOXIDEGuangzhou Hoegoa Biotechnology Co., Ltd.44b37930-b302-338c-e063-6394a90a5f7f2025-11-28WarningsExact identifier
application number: M020
OCEAURA Glitter SunscreenTITANIUM DIOXIDEGuangzhou Oceaura Biotechnology Co., Ltd.44b47284-57cd-2e61-e063-6394a90a50722025-11-28WarningsExact identifier
application number: M020
OUHOE Moisturizing And Translucent SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.34e8e4a6-2782-9a3d-e063-6394a90a84c22025-11-27WarningsExact identifier
application number: M020
OUHOE Protection SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.4272dcef-eda5-1013-e063-6294a90adf382025-11-27WarningsExact identifier
application number: M020
OUHOE SunscreenTITANIUM DIOXIDEShantou Ouhoe Technology Co., Ltd.42fcc9ed-083c-6582-e063-6394a90ae9e62025-11-27WarningsExact identifier
application number: M020
EELHOE Sun CreamTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.305cb87e-450f-840a-e063-6294a90a883f2025-11-27WarningsExact identifier
application number: M020
EELHOE Bio Sun StickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.349a3d72-9969-855d-e063-6394a90a281c2025-11-27WarningsExact identifier
application number: M020
EELHOE Cica Cooling Sun StickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.305c13af-0843-f478-e063-6394a90a42de2025-11-27WarningsExact identifier
application number: M020
EELHOE Quick Sun Stick Protection BarTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.3578c958-a457-402b-e063-6394a90a73422025-11-27WarningsExact 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