FDA.reportPublic FDA data

Oil-Free Foaming Acne Wash Facial Cleanser

Manufacturer
Rejoice International | China Ningbo Shangge Cosmetic Technology Corp
Effective date
2024-02-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:09:08

Label at a glance#

ProductOil-Free Foaming Acne Wash Facial Cleanser Grapefruit
Active ingredientSALICYLIC ACID
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                                         Purpose

Salicylic Acid 2.0% ............................. Acne Treatment

OTC - PURPOSE SECTION

XtraCare Oil-Free Foaming Acne Wash Facial Cleanser

PINK GRAPEFRUIT SCENT

gentle cleansing for acne

Salicylic Acid 2%

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. Avoid contact with eyes. If contact occurs, flush thoroughly with water.

INDICATIONS & USAGE SECTION

This XtraCare acne wash gently cleanses breakouts you already have and helps prevent them from returning. It works deep to clean and soothe without overdrying or irritating skin. Rinses clean, leaving no residue to clog pores.

WARNINGS SECTION

Warnings

For external use only.

May stain some fabrics

When using this product and other topical acne medications at the same time or immediately following use of this product, dryness or irritation of the skin may be increased.  If this occurs, only one medication should be used unless directed by a doctor.

DOSAGE & ADMINISTRATION SECTION

Directions

Wet face. Gently massage product all over face for 20-30 seconds, avoiding eye area. Rinse thoroughly and pat dry. Cleanse twice daily

INACTIVE INGREDIENT SECTION

Inactive Ingredients: water, sodium c14-16 olefin sulfonate, cocamidopropyl betaine, acrylates copolymer, propylene glycol, sodium lauryl sulfate, fragrance, citric acid, aloe barbadensis leaf juice, disodium EDTA, sodium hydroxide, fd&c red no.33

OTHER SAFETY INFORMATION

Other information

store at 20o to 25oC (68o to 77oF)

DISTRIBUTED BY

REJOICE INTERNATIONAL INC

48325 BINGHAMPTON DR

NORTHVILLE, MI 48168 USA

MADE IN CHINA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

label imagelabel image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
562600salicylic acid 2 % Medicated Liquid SoapPSN3
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD3
562600salicylic acid 2 % Facial Cleanser TonerSY3
562600salicylic acid 2 % Facial ScrubSY3
562600salicylic acid 2 % Medicated Liquid SoapSY3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
57337-033-012024-02-28C16284748780-11030e365-6028-111a-e063-dadaa90a10e2Oil-Free Foaming Acne Wash Facial Cleanser
57337-033-012024-01-30C16284748780-11030e365-6028-111a-e063-dadaa90a10e2Oil-Free Foaming Acne Wash Facial Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57337-033-01Oil-Free Foaming Acne Wash Facial CleanserGrapefruit177 mg in 1 BOTTLEGEL1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57337-033OIL-FREE FOAMING ACNE WASH FACIAL CLEANSER GRAPEFRUIT (SALICYLIC ACID) GEL [REJOICE INTERNATIONAL]3Current NDC, Legacy NDC, 1 package rows20240229_a31baa57-1dfd-44d6-87a5-1b06377cb8b9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
SALICYLIC ACIDACTIVE INGREDIENTO414PZ4LPZ1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995L1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QP1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KX1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0L1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
PROPYLENEINACTIVE INGREDIENTAUG1H506LY1
SODIUM C14-16 OLEFIN SULFONATEINACTIVE INGREDIENTO9W3D3YF5U1
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32I1
SODIUM LAURYL SULFATEINACTIVE INGREDIENT368GB5141J1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
57337-03357337-033-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LIACT
PROPYLENEAUG1H506LYIACT
SODIUM LAURYL SULFATE368GB5141JIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALOE VERA LEAFZY81Z83H0XIACT
EDETATE DISODIUM7FLD91C86KIACT
SODIUM HYDROXIDE55X04QC32IIACT
D&C RED NO. 339DBA0SBB0LIACT
SALICYLIC ACIDO414PZ4LPZACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route
2 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSHAMPOO / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route
2 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGEL / TOPICAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
D&C RED NO. 33D&C RED NO. 339DBA0SBB0LSHAMPOO / TOPICALNAExact identifier — unii+route
2 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JGEL / TOPICAL0.05 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KGEL / TOPICAL24 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM HYDROXIDESODIUM HYDROXIDE55X04QC32IGEL / TOPICAL70 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM LAURYL SULFATESODIUM LAURYL SULFATE368GB5141JGEL / TOPICAL0.05 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CITRIC ACID MONOHYDRATECITRIC ACID MONOHYDRATE2968PHW8QPGEL / TOPICAL1 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
Oil-Free Foaming Acne Wash Facial Cleanser GrapefruitSALICYLIC ACIDRejoice Internationala31baa57-1dfd-44d6-87a5-1b06377cb8b92024-02-28WarningsExact identifier
ndc (package): 57337-033-01
ndc (product): 57337-033
ndc11 (package): 57337003301
spl id: 126c057a-5b1d-c246-e063-6294a90a6936
spl set id: a31baa57-1dfd-44d6-87a5-1b06377cb8b9

Reported adverse events (FAERS/openFDA)#

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