FDA.reportPublic FDA data

Drug Facts

Manufacturer
L’Oreal USA Products Inc | L'OREAL USA PRODUCTS, INC.
Effective date
2026-05-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:57:33

Label at a glance#

ProductLA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-P...
Active ingredientHOMOSALATE, OCTISALATE, DIMETHICONE, OCTOCRYLENE, ZINC OXIDE
Label structure13 sections

Indications and uses

temporarily protects chapped or cracked skin helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating. Sun Protection Measures . Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in...

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Dimethicone 1%

Homosalate 8%

Octisalate 5%

Octocrylene 5%

Zinc oxide 7%

Purpose

OTC - PURPOSE SECTION

Skin protectant

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • temporarily protects chapped or cracked skin
  • helps prevent sunburn
  • if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating.
  • Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
  • limit time in the sun, especially from 10 a.m. – 2 p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months of age: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, glycerin, propanediol, butyloctyl salicylate, petrolatum, panthenol, dimethicone, butyrospermum parkii (shea) butter, steareth-20, cellulose, ethylhexyl methoxycrylene, polymnia sonchifolia root juice, oryza sativa (rice) bran wax, steareth-2, sorbitan isostearate, madecassoside, triethoxycaprylylsilane, alpha-glucan oligosaccharide, mannose, ammonium polyacryloyldimethyl taurate, hydroxyacetophenone, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, hydroxyethylcellulose, caprylyl glycol, citric acid, trisodium ethylenediamine disuccinate, lactobacillus, maltodextrin, pentylene glycol, polyhydroxystearic acid, polysorbate 60, C12-22 alkyl acrylate/hydroxyethyl acrylate copolymer, chlorphenesin

Questions or comments?

OTC - QUESTIONS SECTION

1-888-LRP-LABO 1-888-577-5226

Monday - Friday (9 a.m. - 5 p.m. EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

15155540 mL carton40 mL cartonlabellabel

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIMETHICONE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codelr.oaqr.io/01/0360600062199240 mL carton.jpg

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

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 39 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82046-99282046-992-01, 82046-992-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 36 matching rows.

Name, UNII, Kind table
NameUNIIKind
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
DIMETHICONE92RU3N3Y1OACTIB
OCTOCRYLENE5A68WGF6WMACTIB
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
PETROLATUM4T6H12BN9UIACT
PANTHENOLWV9CM0O67ZIACT
BUTYROSPERMUM PARKII (SHEA) BUTTERK49155WL9YIACT
STEARETH-20L0Q8IK9E08IACT
POWDERED CELLULOSESMD1X3XO9MIACT
ETHYLHEXYL METHOXYCRYLENES3KFG6Q5X8IACT
POLYMNIA SONCHIFOLIA ROOT JUICEM9S7HX36CTIACT
ORYZA SATIVA (RICE) BRANR60QEP13ICIACT
STEARETH-2V56DFE46J5IACT
SORBITAN ISOSTEARATE01S2G2C1E4IACT
MADECASSOSIDECQ2F5O6YIYIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ALPHA-GLUCAN OLIGOSACCHARIDES95658MI3WIACT
MANNOSEPHA4727WTPIACT
AMMONIUM POLYACRYLOYLDIMETHYL TAURATEF01RIY4371IACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
HYDROXYETHYLCELLULOSET4V6TWG28DIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CITRIC ACID2968PHW8QPIACT
TRISODIUM ETHYLENEDIAMINE DISUCCINATEYA22H34H9QIACT
LACTOBACILLUS5307V7XW8IIACT
MALTODEXTRIN7CVR7L4A2DIACT
PENTYLENE GLYCOL50C1307PZGIACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
POLYSORBATE 60CAL22UVI4MIACT
CHLORPHENESINI670DAL4SZIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-12-05monthly-update2026-06-03 17:45:29

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LA ROCHE POSAY Laboratoire Dermatologique Cicaplast Balm B5 UV Skin Protectant Sunscreen Soothing Therapeutic Multi-Purpose Broad Spectrum SPF 50DIMETHICONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE AND ZINC OXIDELOreal USA Products Inc92a1d6ce-aff3-45fc-8d98-20c4375aded82026-05-14WarningsExact identifier
ndc (package): 82046-992-01
ndc (package): 82046-992-02
ndc (product): 82046-992
ndc11 (package): 82046099201
ndc11 (package): 82046099202
spl id: dbe82016-deec-4bed-a41d-11f1a873728f
spl set id: 92a1d6ce-aff3-45fc-8d98-20c4375aded8

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.