FDA.reportPublic FDA data

Acne Control Serum

Manufacturer
SBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESI
Effective date
2026-01-27
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 01:35:07

Label at a glance#

ProductPROPOLIS NASAL PLUS
Active ingredientOXYMETAZOLINE HYDROCHLORIDE, ZINC OXIDE, SALICYLIC ACID
Label structure19 sections

Dosage and administration

Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years of age when using this product to avoid swallowing.

Storage and handling

Store between 15-30C (59-86F) Avoid freezing and excessive heat above 40C (104F)

Label contents#

Full prescribing information#

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Alcohol 80% v/v. Purpose: Antiseptic

Purpose

OTC - PURPOSE SECTION

Antiseptic, Hand Sanitizer

Use

INDICATIONS & USAGE SECTION

Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

Warnings

WARNINGS SECTION

For external use only. Flammable. Keep away from heat or flame

Do not use

OTC - DO NOT USE SECTION

  • in children less than 2 months of age
  • on open skin wounds

OTC - WHEN USING SECTION

When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.
Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - STOP USE SECTION

Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • Place enough product on hands to cover all surfaces. Rub hands together until dry.
  • Supervise children under 6 years of age when using this product to avoid swallowing.

Other information

STORAGE AND HANDLING SECTION

  • Store between 15-30C (59-86F)
  • Avoid freezing and excessive heat above 40C (104F)

Acne Control Serum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30 ml NDC:​ 82123-009 Acne Control SerumAcne Control Serum

Sunscreen for kids SPF50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sunscreen for kids SPF50 80 mL NDC: 82123-012Sunscreen for kids SPF50 80 mL NDC: 82123-012

Sunscreen for face SPF50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sunscreen for face SPF50 40 mL NDC: 82123-013Sunscreen for face SPF50 40 mL NDC: 82123-013

Aftersun

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AfterSun 80 mL NDC: 82123-004AfterSun 80 mL NDC: 82123-004

Diaper Rash Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diaper Rash CreamDiaper Rash CreamDiaper Rash Cream50 mL NDC: 82123-005

Propolis Nasal Plus

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Nasal Spray Plus NDC: 82123-010Nasal Spray Plus NDC: 82123-010

Propolis Nasal

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Propolis Nasal NDC: 82123-009Propolis Nasal NDC: 82123-009

SOS Cream

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SOS CreamSOS CreamSOS Cream

Sunscreen SPF50

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sunscreen SPF50 80 mL NDC: 82123-011Sunscreen SPF50 80 mL NDC: 82123-011

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130190853001672GTIN-13: 0190853001672
EAN-13: 0190853001672
GTIN-12: 190853001672
UPC-A: 190853001672
GTIN storage (14 digits): 00190853001672		Sunscreen SPF50.jpg
BarcodeEAN-130190853001702GTIN-13: 0190853001702
EAN-13: 0190853001702
GTIN-12: 190853001702
UPC-A: 190853001702
GTIN storage (14 digits): 00190853001702		Sunscreen for kids SPF50.jpg
BarcodeEAN-130190853002433GTIN-13: 0190853002433
EAN-13: 0190853002433
GTIN-12: 190853002433
UPC-A: 190853002433
GTIN storage (14 digits): 00190853002433		ed6dd06d-cdd7-ee7f-e053-2995a90a3fcd.jpg, SOS Cream.jpg
BarcodeEAN-130190853003508GTIN-13: 0190853003508
EAN-13: 0190853003508
GTIN-12: 190853003508
UPC-A: 190853003508
GTIN storage (14 digits): 00190853003508		Acne Control Serum.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
e67be450-f8e4-4bc1-88bd-1259d379f55fProduct name120210127
c53f3286-4062-4cf5-8355-399519c639a6Product name120170424
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
a993dfc5-f219-4460-bde6-30dd724d9ef0Product name120160818

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82123-001-812022-11-15C16284748780-1e4f33bdf-9e72-d8a0-e053-dadaa90a6e4ec5d52f13-a649-9579-e053-2a95a90a062c
82123-002-812022-11-15C16284748780-1e4f33bdf-9e72-d8a0-e053-dadaa90a6e4ec5d52f13-a649-9579-e053-2a95a90a062c
82123-003-412022-11-15C16284748780-1e4f33bdf-9e72-d8a0-e053-dadaa90a6e4ec5d52f13-a649-9579-e053-2a95a90a062c
82123-004-812022-11-15C16284748780-1e4f33bdf-9e72-d8a0-e053-dadaa90a6e4ec5d52f13-a649-9579-e053-2a95a90a062c
82123-005-512022-11-15C16284748780-1e4f33bdf-9e72-d8a0-e053-dadaa90a6e4ec5d52f13-a649-9579-e053-2a95a90a062c
82123-006-162022-11-15C16284748780-1e4f33bdf-9e72-d8a0-e053-dadaa90a6e4ec5d52f13-a649-9579-e053-2a95a90a062c
82123-001-812022-07-29C16284748780-1e4f33bdf-9e72-d8a0-e053-dadaa90a6e4ec5d52f13-a649-9579-e053-2a95a90a062c
82123-002-812022-07-29C16284748780-1e4f33bdf-9e72-d8a0-e053-dadaa90a6e4ec5d52f13-a649-9579-e053-2a95a90a062c
82123-003-412022-07-29C16284748780-1e4f33bdf-9e72-d8a0-e053-dadaa90a6e4ec5d52f13-a649-9579-e053-2a95a90a062c
82123-004-812022-07-29C16284748780-1e4f33bdf-9e72-d8a0-e053-dadaa90a6e4ec5d52f13-a649-9579-e053-2a95a90a062c
82123-005-512022-07-29C16284748780-1e4f33bdf-9e72-d8a0-e053-dadaa90a6e4ec5d52f13-a649-9579-e053-2a95a90a062c
82123-006-162022-07-29C16284748780-1e4f33bdf-9e72-d8a0-e053-dadaa90a6e4ec5d52f13-a649-9579-e053-2a95a90a062c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82123-014-80Sunscreen SPF5080 mL in 1 TUBECREAM809
82123-014-81Sunscreen SPF501 in 1 TUBECREAM19
82123-015-80Sunscreen for kids SPF5080 mL in 1 TUBECREAM809
82123-015-81Sunscreen for kids SPF501 in 1 TUBECREAM19
82123-016-40Sunscreen for Face SPF5040 mL in 1 TUBECREAM409
82123-016-41Sunscreen for Face SPF501 in 1 TUBECREAM19
82123-018-15S.O.S Cream Intensive Moisturizing Skin Protectant15 mL in 1 CONTAINERCREAM159
82123-018-16S.O.S Cream Intensive Moisturizing Skin Protectant1 in 1 BOXCREAM19
82123-019-30Acne Control Serum30 mL in 1 BOTTLE, GLASSLIQUID309
82123-019-31Acne Control Serum1 in 1 BOXLIQUID19
82123-020-30PROPOLIS NASAL30 mL in 1 BOTTLE, GLASSLIQUID309
82123-020-31PROPOLIS NASAL1 in 1 BOXLIQUID19
82123-021-30PROPOLIS NASAL PLUS30 mL in 1 BOTTLE, GLASSLIQUID309
82123-021-31PROPOLIS NASAL PLUS1 in 1 BOXLIQUID19
82123-022-50Diaper Rash Cream50 mL in 1 TUBECREAM509
82123-022-51Diaper Rash Cream1 in 1 TUBECREAM19
82123-023-80AfterSun80 mL in 1 TUBECREAM809
82123-023-81AfterSun1 in 1 TUBECREAM19

Products#

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

DailyMed product names page 1 of 2 · 63 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82123-01482123-014-80, 82123-014-81
82123-01582123-015-80, 82123-015-81
82123-01682123-016-40, 82123-016-41
82123-02382123-023-80, 82123-023-81
82123-01882123-018-15, 82123-018-16
82123-01982123-019-30, 82123-019-31
82123-02082123-020-30, 82123-020-31
82123-02182123-021-30, 82123-021-31
82123-02282123-022-50, 82123-022-51

Ingredients#

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

DailyMed ingredient rows page 1 of 4 · 124 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUCALYPTUS OIL2R04ONI662IACT
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB
WATER059QF0KO0RIACT
SEA SALT87GE52P74GIACT
PROPOLIS WAX6Y8XYV2NOFIACT
GLYCERINPDC6A3C0OXIACT
EUCALYPTUS OIL2R04ONI662IACT
SEA SALT87GE52P74GIACT
GLYCERINPDC6A3C0OXIACT
PROPOLIS WAX6Y8XYV2NOFIACT
OXYMETAZOLINE HYDROCHLORIDEK89MJ0S5VYACTIB
WATER059QF0KO0RIACT
WATER059QF0KO0RIACT
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES0C9AC7D6XUIACT
JOJOBA OIL724GKU717MIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ZINC OXIDESOI2LOH54ZACTIB
PROPOLIS WAX6Y8XYV2NOFIACT
PANTHENOLWV9CM0O67ZIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
MAGNESIUM SULFATE ANHYDROUSML30MJ2U7IIACT
ALOE VERA LEAFZY81Z83H0XIACT
ARGAN OIL4V59G5UW9XIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
GLYCERYL CITRATE4987GT719IIACT
GLYCERINPDC6A3C0OXIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
OLEA EUROPAEA (OLIVE) OIL UNSAPONIFIABLESXO45V955LTIACT
ZINC OXIDESOI2LOH54ZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
PANTHENOLWV9CM0O67ZIACT
BUTYROSPERMUM PARKII (SHEA) BUTTER UNSAPONIFIABLES0C9AC7D6XUIACT
MAGNESIUM SULFATE ANHYDROUSML30MJ2U7IIACT
GLYCERYL CITRATE4987GT719IIACT
PROPOLIS WAX6Y8XYV2NOFIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT

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
Sunscreen SPF50NON NANO ZINC OXIDESBS BILIMSEL BIO COZUMLER SANAYI VE TICARET ANONIM SIRKETI PINAR SUBESIc5d52f13-a649-9579-e053-2a95a90a062c2026-01-27WarningsExact identifier
ndc (package): 82123-022-50
ndc (package): 82123-020-31
ndc (package): 82123-015-80
ndc (package): 82123-022-51
ndc (package): 82123-021-30
ndc (package): 82123-019-30
ndc (package): 82123-016-41
ndc (package): 82123-023-81
ndc (package): 82123-023-80
ndc (package): 82123-019-31
ndc (package): 82123-015-81
ndc (package): 82123-021-31
ndc (package): 82123-014-81
ndc (package): 82123-018-16
ndc (package): 82123-018-15
ndc (package): 82123-020-30
ndc (package): 82123-014-80
ndc (package): 82123-016-40
ndc (product): 82123-015
ndc (product): 82123-021
ndc (product): 82123-022
ndc (product): 82123-020
ndc (product): 82123-016
ndc (product): 82123-014
ndc (product): 82123-019
ndc (product): 82123-018
ndc (product): 82123-023
ndc11 (package): 82123002250
ndc11 (package): 82123002380
ndc11 (package): 82123001581
ndc11 (package): 82123001815
ndc11 (package): 82123002031
ndc11 (package): 82123001641
ndc11 (package): 82123001480
ndc11 (package): 82123002030
ndc11 (package): 82123001816
ndc11 (package): 82123001931
ndc11 (package): 82123002131
ndc11 (package): 82123001640
ndc11 (package): 82123002381
ndc11 (package): 82123001580
ndc11 (package): 82123001930
ndc11 (package): 82123002130
ndc11 (package): 82123001481
ndc11 (package): 82123002251
spl id: 495e0d14-b3c3-42c0-e063-6394a90a89fe
spl set id: c5d52f13-a649-9579-e053-2a95a90a062c

Reported adverse events (FAERS/openFDA)#

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