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 80 of 357 · 7,139 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NELLY DEVUYST BIOSOLAR COLORLIFT 3 TINTED SUNSCREEN SPF30ZINC OXIDELABORATOIRES DRUIDE INC19af4441-31b2-72db-e063-6394a90a813c2026-01-14WarningsExact identifier
application number: M020
Sqween Paint-On Sun Protection for Independent Kids Mineral Sunscreen SPF 30ZINC OXIDESqween LLC9c3cf35b-4bde-46e3-8abd-5f4d1ad6e4862026-01-14WarningsExact identifier
application number: M020
SCENTUAL AROMA BEAUTY SUN VEIL SPF30TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES DRUIDE INC0799ac38-9a41-6579-e063-6394a90ac4b62026-01-14WarningsExact identifier
application number: M020
NUDA CANADA SOLARGLOW MINERAL SERUM SUNSCREEN SPF30ZINC OXIDELABORATOIRES DRUIDE INC0b412e24-baf6-e68e-e063-6394a90a5f492026-01-14WarningsExact identifier
application number: M020
Dr. C. Tuna Sun Stick SPF 50AVOBENZONE, OCTINOXATE, HOMOSALATE, OCTOCRYLENETAN ALIZE KOZMETIK VE TEMIZLIK URUNLERI SANAYI VE TICARET ANONIM SIRKETIfc89d1b5-1ffe-4f06-8c5c-31f2eb0b56412026-01-14WarningsExact identifier
application number: M020
Oiana Mineral Sunscreen DropsZINC OXIDEOiana LLC4860257d-a8bf-7ce5-e063-6394a90a74db2026-01-14WarningsExact identifier
application number: M020
Standard Procedure Lip Balm SPF 50ZINC OXIDE HOMOSALATE OCTOCRYLENEStandard Procedure Inc1e3db995-b1c5-3a2e-e063-6294a90af75e2026-01-14WarningsExact identifier
application number: M020
Standard Procedure SPF 50 SunscreenHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEStandard Procedure Inc1d3f87de-90c0-75c0-e063-6394a90a2ef42026-01-14WarningsExact identifier
application number: M020
EELHOE Bio Sun StickTITANIUM DIOXIDEShantou Eelhoe Daily Chemical Technology Co., Ltd.48654406-505b-518b-e063-6394a90a5add2026-01-14WarningsExact identifier
application number: M020
JAYSUING Hyaluronic Acid Moisturizing SunscreenTITANIUM DIOXIDEShantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.48662fae-2d41-4a4a-e063-6394a90a15222026-01-14WarningsExact identifier
application number: M020
CALIFORNIA ALOE FRESH POW DERY SUNHOMOSALATE, OCTOCRYLENE, ETHYLHEXYL SALICYLATE, BUTYL METHOXYDIBENZOYLMETHANENATURE REPUBLIC CO., LTD.aa10dbbf-97b3-4258-bbd3-0d8cc9935e122026-01-13WarningsExact identifier
application number: M020
COSRXVITAMIN E VITALIZING SUNSCREENCOSRX inc.4840f608-944a-3e3d-e063-6394a90a1d9d2026-01-13WarningsExact identifier
application number: M020
Neutrogena Invisible Daily Defense Face Serum Sunscreen Broad Spectrum SPF 60 PlusAVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENEKenvue Brands LLCb043f0f3-b263-4c49-86ca-9ecc71a22aa82026-01-13WarningsExact identifier
application number: M020
ARAMORE MULTI-DEFENSE SUNSCREEN - AM Broad Spectrum SPF 30ZINC OXIDENew Frontier Bio, Incef6c8443-fd10-2022-e053-2a95a90a45ea2026-01-13WarningsExact identifier
application number: M020
Bluevado SunfixZINC OXIDE, TITANIUM DIOXIDEMagic Blue, LLC2e5315bf-39f4-401c-8207-18ef6a97e0242026-01-13WarningsExact identifier
application number: M020
Intellishade TruPhysical SPF 45TITANIUM DIOXIDE, ZINC OXIDERevision, LLCe20f5dc9-e863-b090-e053-2a95a90a50442026-01-13WarningsExact identifier
application number: M020
Intellishade TruPhysical Clear SPF 50TITANIUM DIOXIDE, ZINC OXIDERevision, LLC1305fa94-47d5-7a42-e063-6394a90a0aba2026-01-13WarningsExact identifier
application number: M020
Intellishade Clear SPF 50AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATERevision, LLCe213b46d-d061-dc83-e053-2995a90ad8752026-01-13WarningsExact identifier
application number: M020
Intellishade Matte SPF 45OCTINOXATE, OCTISALATE, TITANIUM DIOXIDE, ZINC OXIDERevision, LLCe213ae87-4db2-3070-e053-2995a90a083b2026-01-13WarningsExact identifier
application number: M020
Sun Project MoistureHOMOSALATE, ETHYLHEXYL METHOXYCINNAMATE, ETHYLHEXYL SALICYLATE, OCTOCRYLENE, BUTYL METHOXYDIBENZOYLMETHANETHANK YOU FARMER CO., LTD20a83f02-d851-4aac-e063-6394a90ae1a62026-01-13WarningsExact 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