FDA.reportPublic FDA data

Cicatricure Brightening Cream With SPF

Manufacturer
Prime Labs LLC dba Quality CDMO
Effective date
2025-11-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-06-03 17:45:07

Label at a glance#

ProductCicatricure Brightening Cream With SPF Sunscreen
Active ingredientAVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE
Label structure9 sections

Indications and uses

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

apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating. 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 factor of 15 or higher and other skin protection measures including: limit time in the sun, especially from 10am...

Storage and handling

protect product from excessive heat and direct sun may stain some fabrics keep this carton for future reference.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
OCTINOXATE, 7.5%Sunscreen
OCTISALATE, 4.5%Sunscreen
HOMOSALATE, 4.5%Sunscreen
OXYBENZONE, 3%Sunscreen
AVOBENZONE, 1%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

OTC - DO NOT USE SECTION

Do not useon damaged or broken skin

OTC - WHEN USING SECTION

When using this productkeep out of eyes.

Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctorif rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use

SPL UNCLASSIFIED SECTION

  • apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating.

Sun Protection Measures

SPL UNCLASSIFIED SECTION

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 factor of 15 or higher and other skin protection measures including:

  • limit time in the sun, especially from 10am to 2pm
  • wear long-sleeved shirts, pants, hats and sunglasses
  • children under 6 months of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • protect product from excessive heat and direct sun
  • may stain some fabrics
  • keep this carton for future reference.

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, GLYCERIN, ALCOHOL, POLYSORBATE 60, SORBITAN STEARATE, BUTYLENE GLYCOL, TRIETHANOLAMINE, CARBOMER, BENZYL ALCOHOL, PHENOXYETHANOL, METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER, POLYSORBATE 20, HYDROLYZED OAT PROTEIN, PPG-2 MYRISTYL ETHER PROPIONATE, ETHYL ASCORBIC ACID, ALPHA-ARBUTIN, ETHYLHEXYLGLYCERIN, SILANEDIOL SALICYLATE, MELANIN, PALMITOYL TRIPEPTIDE-1, PALMITOYL TETRAPEPTIDE-7, 3-0- ETHYL ASCORBIC ACID

Questions

OTC - QUESTIONS SECTION

Call toll free +1 682-812-2222

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL - 50 ml Bottle CartonPRINCIPAL DISPLAY PANEL - 50 ml Bottle Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80587-18680587-186-01, 80587-186-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
PPG-2 MYRISTYL ETHER PROPIONATE88R97D8U8AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PALMITOYL TRIPEPTIDE-1RV743D216MIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 60CAL22UVI4MIACT
POLYSORBATE 207T1F30V5YHIACT
SORBITAN STEARATENVZ4I0H58XIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CARBOMER0A5MM307FCIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OXYBENZONE95OOS7VE0YACTIB
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLYCOL DIMETHACRYLATE7BK5G69305IACT
TRIETHANOLAMINE9O3K93S3TKIACT
SODIUM HYDROXIDE55X04QC32IIACT
BENZYL ALCOHOLLKG8494WBHIACT
SILANEDIOL SALICYLATEC054DF30K0IACT
ALPHA-ARBUTIN72VUP07IT5IACT
3-O-ETHYL ASCORBIC ACID6MW60CB71PIACT

Source Document#

Source XML

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
440bf8e1-3f8d-d1f5-e063-6294a90a3485440bf60f-d942-e2f4-e063-6394a90a03c82025-11-20WarningsExact identifier
spl id: 440bf8e1-3f8d-d1f5-e063-6294a90a3485
spl set id: 440bf60f-d942-e2f4-e063-6394a90a03c8

Reported adverse events (FAERS/openFDA)#

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