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 254 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BABYGANICS SPF 50 Plus SUNSCREENZINC OXIDE, OCTISALATE, AND OCTOCRYLENEKAS Direct LLC dba Babyganics4075f9dc-c25f-434f-a3fc-a7f896295c3d2024-12-20WarningsExact identifier
application number: M020
SunscreenHOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONETotal Resources International7d4f820d-e154-428e-89c2-2e26e088ceef2024-12-20WarningsExact identifier
application number: M020
Babyganics Sheer Blend SPF50 Mineral SunscreenZINC OXIDEKAS Direct LLC dba BabyGanicsedced0dc-dd43-4ac9-b816-f4edb45fc87b2024-12-20WarningsExact identifier
application number: M020
NARS Radiance Primer Broad Spectrum SPF 35 SunscreenOCTISALATE, OCTOCRYLENE, AVOBENZONE, HOMOSALATECOSMAX USA, CORPORATION29ad7391-d932-3549-e063-6394a90ab2b22024-12-20WarningsExact identifier
application number: M020
Face Reality daily spf 30 plus Sunscreen SPF 30HOMOSALATE, OCTISALATE, AVOBENZONEFace Reality,LLC45a3ce12-15fe-4040-95da-ac8513a39fb92024-12-20WarningsExact identifier
application number: M020
Face Reality mineral matte spf 28 Sunscreen SPF 28ZINC OXIDE, TITANIUM DIOXIDEFace Reality, LLC29b70afe-cf9d-d0ba-e063-6394a90a1cc42024-12-20WarningsExact identifier
application number: M020
Sonage Roux Tinted Day Creme with SPF 30 Sheer Tinted MoisturizerZINC OXIDEASA Universal Inc. dba: Sonagefd14d70c-6cd0-5de6-e053-6294a90a7add2024-12-20WarningsExact identifier
application number: M020
Coola SPF 50 ClassicSUNSCREEN FACE MISTCOOLA LLCd18d0dac-5690-436e-e053-2995a90a02542024-12-20WarningsExact identifier
application number: M020
COOLA Mineral Body SPF 30 Tropical CoconutZINC OXIDECOOLA, LLCeeb5d4f1-8cba-9ef6-e053-2a95a90a823f2024-12-20WarningsExact identifier
application number: M020
Oars and Alps SPF 50 100% Mineral Antioxidant SunscreenTITANIUM DIOXIDE, ZINC OXIDEOars and Alps LLCf3971b85-a13e-4195-e053-2995a90a73cb2024-12-20WarningsExact identifier
application number: M020
Vacation SPF 30 MineralZINC OXIDEVacation Inc.f69513ae-f210-075f-e053-2a95a90a9b2e2024-12-20WarningsExact identifier
application number: M020
Vacation SPF 30 Chardonnay OilAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEVacation Inc.f694752d-4839-3768-e053-2995a90a5d3e2024-12-20WarningsExact identifier
application number: M020
Oars and Alps SPF 50 Hydrating Antioxidant SunscreenSprayAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOars and Alps LLCec5b82f5-b36c-fbc5-e053-2995a90afa0c2024-12-20WarningsExact identifier
application number: M020
Oars and Alps SPF 70 Hydrating Antioxidant SunscreenAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEOars and Alps LLCf39673a7-0b62-bdf7-e053-2995a90aa2b72024-12-20WarningsExact identifier
application number: M020
Carpe SPF 30 Face PrimerTITANIUM DIOXIDE, ZINC OXIDEClutch, Inc. DBA Carpefeac5ee2-faa5-fd17-e053-6394a90a7f992024-12-20WarningsExact identifier
application number: M020
Oars and Alps SPF 50 MineralZINC OXIDEOars and Alps LLCf395bc39-daa5-53b8-e053-2995a90a5f482024-12-20WarningsExact identifier
application number: M020
Babyganics Kids Sheer Blend SPF50 Mineral SunscreenZINC OXIDEKAS Direct LLC dba BabyGanics8a143645-3b52-4797-9b26-dc9dd63be38f2024-12-20WarningsExact identifier
application number: M020
Nuria Defend Matte Finish Daily Moisturizer Mineral Sunscreen Broad Spectrum SPF 30TITANIUM DIOXIDE AND ZINC OXIDESmall World Brandsb1df4c81-333b-450d-963e-6670ab9bbda92024-12-20WarningsExact identifier
application number: M020
foundcealer multi-tasking foundation Broad Spectrum SPF 20 Sunscreen 8B porcelain beigeTITANIUM DIOXIDE AND ZINC OXIDETarte, Inc.062fa0d9-f384-48af-8269-42de3a788db12024-12-20WarningsExact identifier
application number: M020
Stokoderm Sunscreen PUREAVOBENZONE, OCTOCRYLENE, OCTISALATE, AND HOMOSALATESC Johnson Professional USA, Inc.3ddf81e6-de78-4f2f-814b-c75eadcddb392024-12-20WarningsExact 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