Cicatricure ® Aqua Defense Day Cream With SPF

Manufacturer
Genomma Lab USA
Effective date
2022-01-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:16:31

Label at a glance#

ProductCicatricure Aqua Defense Day With SPF
Active ingredientAvobenzone, Homosalate, Octisalate, Octocrylene
Label structure10 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 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 2%Sunscreen
Homosalate 5%Sunscreen
Octisalate 4.4%Sunscreen
Octocrylene 9%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 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 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 from excessive heat and direct sun.
  • may stain some fabrics.
  • keep this carton for future reference.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Caprylyl Methicone, Glycerin, PEG-12 Dimethicone/PPG-20 Crosspolymer, Brassica Campestris/Aleurites Fordi Oil Copolymer, Phenoxyethanol, Polyacrylate-13, Polyisobutene, Trehalose, Urea, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Imidazolidinyl Urea, Fragrance, Disodium EDTA, Ethylhexylglycerin, Pentylene Glycol, Polysorbate 20, Serine, Sodium Hydroxide, Pullulan, Algin, Sodium Hyaluronate

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

NEW

With Sunscreen

Cicatricure®
AQUA DEFENSE

DAY CREAM WITH SPF 15

Hydrates while helping fade the
appearance of first expression
lines from daily aggressors

Net Wt. 1.7 OZ (50 g)

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

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-70350066-703-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

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
a302c2a2-d078-4c3d-b18f-0f7c6a4cf286409a8745-98f9-4e5a-b2d0-7b5d19bd12792024-01-17WarningsExact identifier
spl set id: 409a8745-98f9-4e5a-b2d0-7b5d19bd1279

Reported adverse events (FAERS/openFDA)#

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