FDA.reportPublic FDA data

Advanced Anti-Wrinkle Therapy

Manufacturer
Genomma Lab | CGI Packaging, LLC
Effective date
2019-01-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:58:17

Label at a glance#

ProductAdvanced Anti-Wrinkle Therapy Cicatricure
Active ingredientAVOBENZONE, OCTINOXATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
Label structure8 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

For sunscreen use : • 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: 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 inclu...

Label contents#

Full prescribing information#

Active ingredients Purpose

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%........................................Sunscreen

Octinoxate 7.5%.......................................Sunscreen

Octisalate 5%...........................................Sunscreen

Octocrylene 2.7%.....................................Sunscreen

Oxybenzone 4%........................................Sunscreen

OTC - PURPOSE SECTION

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



Do not use on damaged or broken skin

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

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 immediately

Directions

DOSAGE & ADMINISTRATION SECTION



For sunscreen use: • 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: 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water

Glycerin

Dimethicone

Ethylhexyl Methoxycrylene

Neopentyl Glycol Diheptanoate

Glyceryl Stearate

Butylene Glycol

Isostearyl Neopentanoate

PPG-2 Isoceteth-20 Acetate

Polymethyl Methacrylate

Acrylamide/Sodium Acryloyldimethyltaurate Copolymer

Bakuchiol

Retinyl Palmitate

Tocopheryl Acetate

Bisabolol

Cetearyl Alcohol

Sorbitan Oleate

Retinol

Hydroxypinacolone Retinoate

Myristoyl Nanapeptide-3

Palmitoyl Oligopeptide

Palmitoyl Tetrapeptide-7

Tocopherol

Sodium Ascorbate

Sodium Hyaluronate

Caprylic/Capric Triglyceride

Dimethicone Crosspolymer

Acrylates/C10-30 Alkyl Acrylate Crosspolymer

Behenyl Alcohol

Sodium Lactate

Ethylhexylglycerin

Isohexadecane

Polysorbate 80

Polysorbate 20

Dimethyl Isosorbide

Xanthan Gum

Carbomer

Disodium EDTA

Sodium Hydroxide

Pentylene Glycol

Chlorphenesin

Phenoxyethanol

Caprylyl Glycol

Citric Acid

Potassium Sorbate

Fragrance

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50066-121-012020-09-27C16284748780-1ab0e2407-267b-f274-e053-dbdaa90a64717f95544e-c6b8-cd1a-e053-2991aa0ac867
50066-121-012020-09-25C16284748780-1ab0e2407-267b-f274-e053-dbdaa90a64717f95544e-c6b8-cd1a-e053-2991aa0ac867
50066-121-012020-07-22C16284748780-1ab0e2407-267b-f274-e053-dbdaa90a64717f95544e-c6b8-cd1a-e053-2991aa0ac867

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50066-121-01Advanced Anti-Wrinkle TherapyCicatricure1 in 1 CARTONCREAM12
50066-121-01Advanced Anti-Wrinkle TherapyCicatricure42 g in 1 TUBECREAM422

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50066-121ADVANCED ANTI-WRINKLE THERAPY CICATRICURE (AVOBENXONE 3%, OCTINOXATE 7.5%, OCTISALATE 5%, OCTOCRYLENE 2.7%, OXYBENZONE 4%) CREAM [GENOMMA LAB]2Legacy NDC, 2 package rows20190121_7f95544e-c6b8-cd1a-e053-2991aa0ac867.zip

Products#

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

DailyMed product names page 1 of 2 · 49 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50066-12150066-121-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 47 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLENE GLYCOL3XUS85K0RAIACT
ISOSTEARYL NEOPENTANOATE411THY156QIACT
PPG-2 ISOCETETH-20 ACETATEBI6C7YO419IACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
BAKUCHIOLOT12HJU3ARIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
LEVOMENOL24WE03BX2TIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
RETINOLG2SH0XKK91IACT
HYDROXYPINACOLONE RETINOATENJ3V2F02E1IACT
MYRISTOYL PENTAPEPTIDE-4PMA59A699XIACT
PALMITOYL TETRAPEPTIDE-7Q41S464P1RIACT
TOCOPHEROLR0ZB2556P8IACT
SODIUM ASCORBATES033EH8359IACT
HYALURONATE SODIUMYSE9PPT4THIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
DOCOSANOL9G1OE216XYIACT
SODIUM LACTATETU7HW0W0QTIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
ISOHEXADECANE918X1OUF1EIACT
POLYSORBATE 806OZP39ZG8HIACT
POLYSORBATE 207T1F30V5YHIACT
DIMETHYL ISOSORBIDESA6A6V432SIACT
XANTHAN GUMTTV12P4NEEIACT
POLYACRYLIC ACID (8000 MW)73861X4K5FIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM HYDROXIDE55X04QC32IIACT
PENTYLENE GLYCOL50C1307PZGIACT
CHLORPHENESINI670DAL4SZIACT
PHENOXYETHANOLHIE492ZZ3TIACT
CAPRYLYL GLYCOL00YIU5438UIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
AVOBENZONEG63QQF2NOXACTIB
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
7f962f4d-4050-735a-e053-2a91aa0af65c7f95544e-c6b8-cd1a-e053-2991aa0ac8672019-01-14WarningsExact identifier
spl id: 7f962f4d-4050-735a-e053-2a91aa0af65c
spl set id: 7f95544e-c6b8-cd1a-e053-2991aa0ac867

Reported adverse events (FAERS/openFDA)#

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