FDA.reportPublic FDA data

Shine Control Sebum Regulating Gel

Manufacturer
CASMARA COSMETICS, SA
Effective date
2017-02-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:49:05

Label at a glance#

ProductShine Control Sebum Regulating Gel
Active ingredientGLYCERIN
Label structure11 sections

Indications and uses

. facial treatment that regulates the oil secretion

Dosage and administration

. apply to clean face and neck until the product has been absorbed . can be used in the morning and/or night

Label contents#

Full prescribing information#

Active Ingredients Purpose

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients Purpose

Glycerin 8%.................... Skin Protectant

BottleBottle

Uses

INDICATIONS & USAGE SECTION

. facial treatment that regulates the oil secretion

Uses

OTC - PURPOSE SECTION

. facial treatment that regulates the oil secretion

Warnings

WARNINGS SECTION

For external use only.

Do not use on damaged or broken skin.

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

Stop use and ask a doctor if rash occurs.

Keep out of reach of children.

Whhen using this product do not get into eyes.

Children under 6 months: as a doctor.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Warnings

OTC - ASK DOCTOR SECTION

Stop use and ask a doctor if rash occurs.

Questions or comments?

OTC - QUESTIONS SECTION

(305) 777-0548 M-F 9:00 am to 5:00 pm

Directions

INSTRUCTIONS FOR USE SECTION

. apply to clean face and neck until the product has been absorbed

. can be used in the morning and/or night

Other information

OTHER SAFETY INFORMATION

. keep the product in a cool and dry place.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Butylene glycol dicaprylate/dicaprate, Ammonium acryloyl dimethyltaurate/VP copolymer, Potassium azeloyl diglycinate, Phenoxyethanol, Fragrance, Lactic acid, Ethylhexylglycerin, Tetrasodium glutamate diacetate

Directions

DOSAGE & ADMINISTRATION SECTION

. apply to clean face and neck until the product has been absorbed

. can be used in the morning and/or night

Shine Control

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Shine control
Sebum Regulating Gel

Oily Blemish Prone Skin

BoxBox

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
20151-095-022020-01-31C16284748780-19d75b9d0-5554-f424-e053-dadaa90a57ceShine Control Sebum Regulating Gel Oily Blemish Prone Skin

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
20151-095-01Shine Control Sebum Regulating Gel50 mL in 1 BOTTLE, PLASTICGEL501
20151-095-02Shine Control Sebum Regulating Gel1 in 1 BOTTLE, PLASTICGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
20151-095SHINE CONTROL SEBUM REGULATING GEL (GLYCERIN) GEL [CASMARA COSMETICS, SA]1Legacy NDC, 2 package rows20170303_4973905f-dabf-2cc5-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
20151-09520151-095-01, 20151-095-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
POTASSIUM AZELOYL DIGLYCINATEN02RVN6NYPIACT
WATER059QF0KO0RIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
LACTIC ACID33X04XA5ATIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
BUTYLENE GLYCOL DICAPRYLATE/DICAPRATE75D21FL1PIIACT
PHENOXYETHANOLHIE492ZZ3TIACT
GLYCERINPDC6A3C0OXACTIB

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
4973905f-dac0-2cc5-e054-00144ff8d46c4973905f-dabf-2cc5-e054-00144ff8d46c2017-02-26WarningsExact identifier
spl id: 4973905f-dac0-2cc5-e054-00144ff8d46c
spl set id: 4973905f-dabf-2cc5-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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