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 314 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 DeepTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc83725be5-4a0a-4717-a034-ff2999dd40992023-12-16WarningsExact identifier
application number: M020
Light Day Sunscreen SPF 37AVOBENZONE, OCTINOXATE, OCTOCRYLENECircadia by Dr Pugliese, Inc.16d76785-22a0-4a4b-a6f1-74056612e9362023-12-15WarningsExact identifier
application number: M020
ERBORIAN - BB CREME NUDE SPF20OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDELABORATOIRES M&L337a771e-c965-421a-a8e7-d853ffe51c2c2023-12-15WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 MediumTITANIUM DIOXIDE AND ZINC OXIDECosmetique Active Productionb4cef09a-f0e4-4054-a200-667df7d150bf2023-12-15WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios Tinted Mineral Light Fluid Sunscreen Broad Spectrum SPF 40 MediumTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc1f3b56d5-c33a-401f-8c8a-924345a4846e2023-12-15WarningsExact identifier
application number: M020
Rejuvity moisturizing day cream BROAD SPECTRUM SPF 15 SUNSCREENTITANIUM DIOXIDE, ZINC OXIDEIsagenix International, LLC6d2d5590-5f53-48d9-94c5-fe9f6a5cf3ce2023-12-14WarningsExact identifier
application number: M020
bareMinerals BAREPRO Performance Wear Liquid Foundation Broad Spectrum SPF 20 Fair 01TITANIUM DIOXIDEOrveon Global US LLC29738578-6681-476e-8660-7219f58e8fa02023-12-13WarningsExact identifier
application number: M020
Sheer Mineral Sunscreen Broad Spectrum SPF 30ZINC OXIDEAllure Labs0c6ac094-cb5b-0f09-e063-6394a90a9eed2023-12-13WarningsExact identifier
application number: M020
REDEFINE Triple DefenseAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OCTISALATERodan & Fieldsed0209a6-a8ce-4394-bcf0-32d585a6b8342023-12-13WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDE AND ZINC OXIDECosmetique Active Production4e56f3f2-b856-4bbc-ab39-6fb5887a48462023-12-13WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Mineral Ultra Light SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products Inc2ce83dc2-84b6-43fd-8b11-495d41cebc222023-12-13WarningsExact identifier
application number: M020
La Roche Posay Laboratoire Dermatologique Anthelios 50 Tinted Mineral Face Broad Spectrum SPF 50 SunscreenTITANIUM DIOXIDECosmetique Active Production4d5d1e79-7b3e-41b5-ae6b-a3b0265702ca2023-12-13WarningsExact identifier
application number: M020
6000X Elemental Screen BS SPF 30 SunscreenZINC OXIDEAllure Labs0c574a9a-edea-d333-e063-6394a90a41e32023-12-12WarningsExact identifier
application number: M020
RODAN FIELDS SOOTHE 4 Mineral Sunscreen BROAD SPECTRUM SPF 30TITANIUM DIOXIDERodan & Fields1a936053-2be0-4c52-a073-ba846b87f8112023-12-12WarningsExact identifier
application number: M020
Beet the sun lightweight sunscreen broad spectrum spf 40 paAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENEKrave Beauty, LLCff93d086-ec80-6bd5-e053-6294a90af0192023-12-12WarningsExact identifier
application number: M020
Broad Spectrum SPF 30 Up The AntiTITANIUM DIOXIDE, ZINC OXIDEBiopelle, Inc.37506766-370e-4ae4-8dbe-915a763e7c552023-12-12WarningsExact identifier
application number: M020
INTELLIGENT BEAUTY LABS Age Defying Day Broad Spectrum SPF 20AVOBENZONE, OCTINOXATE, OCTISALATEDermStore, LLC19640e0c-c6b3-43b8-91e9-d8d9fff2e44e2023-12-12WarningsExact identifier
application number: M020
Dr. Perrys Day Thyme SPF 20 Broad Spectrum SunscreenZINC OXIDEEnglewood Lab, Inc.273d8e30-a6bc-4b26-919c-9332fd5197fa2023-12-12WarningsExact identifier
application number: M020
Youth Activating BB SPF30 Shade 3ZINC OXIDE, TITANIUM DIOXIDEEnglewood Lab, Inc.c84207c4-a779-4c00-a486-86eaf8ece1692023-12-12WarningsExact identifier
application number: M020
Rodan and Fields ESSENTIALS Lip Shield Broad Spectrum SPF 25AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENERodan & Fieldsc7526b69-d059-499a-9134-3a1f5d0471b32023-12-12WarningsExact 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