FDA.reportPublic FDA data

Cicatricure ® Gold Day Cream With SPF

Manufacturer
Genomma Lab USA
Effective date
2020-04-24
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 23:34:23

Label at a glance#

ProductCicatricure Gold Day With SPF
Active ingredientAvobenzone, Homosalate, Octocrylene, Octisalate, Sulisobenzone
Label structure10 sections

Indications and uses

helps prevent sunburn

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 value of 15 or higher and other skin protection measures including: limit time in the sun, especially from 10am ...

Storage and handling

protect 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
Avobenzone 3%Sunscreen
Homosalate 6%Sunscreen
Octocrylene 10%Sunscreen
Octisalate 5%Sunscreen
Sulisobenzone 3%Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • helps prevent sunburn

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if 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 value 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 from excessive heat and direct sun.
  • may stain some fabrics.
  • keep this carton for future reference.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua, Glycerin, Dicaprylyl Carbonate, Polymethylsilsesquioxane, Caprylic/Capric Triglyceride, Caprylyl Methicone, Phenoxyethanol, Glyceryl Stearate, Cetyl Alcohol, Potassium Cetyl Phosphate, Sodium Polyacrylate, Dimethicone, PEG-75 Stearate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Parfum, Ceteth-20, Cyclopentasiloxane, Disodium EDTA, Steareth-20, Ethylhexylglycerin, Sodium Hydroxide, Paeonia Albiflora Root Extract, PEG/PPG-18/18 Dimethicone, Trideceth-6, Hyaluronic Acid, Silanetriol, Iron Oxides (CI 77492, CI 77491), Calcium Chloride, N-Prolyl Palmitoyl Tripeptide-56 Acetate, Bis-Hydroxyethoxypropyl Dimethicone/PEG-2 Soyamine/IPDI Copolymer, Isopropyl Titanium Triisostearate, Colloidal Gold, Acetyl Heptapeptide-9, Alpha-Isomethyl Ionone, Citronellol, Limonene.

Questions?

OTC - QUESTIONS SECTION

Call toll free 1 877-994-3666 Monday to Friday, 8am to 6pm, Central time

SPL UNCLASSIFIED SECTION

Distributed by:
Genomma Lab USA Inc.
Houston, TX 77027

PRINCIPAL DISPLAY PANEL - 50 g Jar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cicatricure®

GOLD LIFT
WITH SUNSCREEN

DAY CREAM WITH SPF 30

REDUCES THE APPEARANCE
OF GRAVITATIONAL WRINKLES
IN 6 WEEKS*

LIFTING EFFECT + NOURISHMENT
LIFTS FACIAL CONTOUR

Net Wt. 1.7 OZ (50g)

* Based on consumer study. Results may vary.

PRINCIPAL DISPLAY PANEL - 50 g Jar Carton
PRINCIPAL DISPLAY PANEL - 50 g Jar Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50066-706-012025-01-10C16284748780-1c7ccaba7-1e0f-fd44-e053-dadaa90aa01bCicatricure ® Gold Day Cream With SPF
50066-706-012021-07-23C16284748780-1c7ccaba7-1e0f-fd44-e053-dadaa90aa01bCicatricure ® Gold Day Cream With SPF

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-70650066-706-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
HomosalateV06SV4M95SACTIB
Octocrylene5A68WGF6WMACTIB
Octisalate4X49Y0596WACTIB
Sulisobenzone1W6L629B4KACTIB
glycerinPDC6A3C0OXIACT
Cetyl alcohol936JST6JCNIACT
Potassium cetyl phosphate03KCY6P7UTIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT
PEG-75 stearateOT38R0N74HIACT
Dimethicone92RU3N3Y1OIACT

Source Document#

Source XML · Source PDF

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
2b5ef895-60c1-c7e4-e063-6394a90a810aabbbc801-3bcc-4cf9-9969-79907dc5fc7a2025-01-10WarningsExact identifier
spl set id: abbbc801-3bcc-4cf9-9969-79907dc5fc7a

Reported adverse events (FAERS/openFDA)#

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