FDA.reportPublic FDA data

Acne Advanced Clarifying Hydrator

Manufacturer
Eminence Organic Skin Care Ltd.
Effective date
2023-12-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:03:47

Label at a glance#

ProductAcne Advanced Clarifying Hydrator
Active ingredientSALICYLIC ACID
Label structure10 sections

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 1%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use

INDICATIONS & USAGE SECTION

  • For the treatment of acne.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • Skin irritation and dryness are more likely to occur when using another topical acne product at the same time. if irritation occurs, use only one product at a time.
  • avoid eye area. In case of eye contact, flush gently and thoroughly with water.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contaact Poison Control Center right away.

Direcitons

DOSAGE & ADMINISTRATION SECTION

  • Cleanse skin thoroughly before applying this product 
  • Apply a layer over the entire face and neck 1 to 3 times daily and leave on.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 ot 3 times daily if needed or as directed by a doctor. If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Other information

SPL UNCLASSIFIED SECTION

Store in controlled temperatures (4-20°C/39-68°F). Keep in a dark and dry place. Keep container tightly closed. 

Inactive ingredients

INACTIVE INGREDIENT SECTION

Organic Phytonutrient Blend (Aloe Barbadensis (Aloe) Juice, Cucumis Sativus (Cucumber) Juice, Salix Alba (Willow) Bark Extract, Rosa Canina (Rosehip) Seed Extract, Citrus Paradisi (Grapefruit) Peel Extract, Symphytum Officinale (Comfrey) Leaf Extract, Lavandula Angustifolia (Lavender) Flower Extract, Equisetum Argense (Horsetail Leaf Extract, Mentha Piperita (Peppermint) Leaf Extract, Calendula Officinalis Flower Extract, Beta Vulgaris (Beetroot) Extract and Vegetable Glycerin], Caprylic/Capric Triglyceride, Hamamelis Virginiana (Witch Hazel), Vegetable Glycerin, Propanediol, Citrus Grandis (Grapefruit) Peel Oil, Mentha Spicata (Spearmint) Leaf Oil, Sodium Acrylate, Nyphaea Caerulea (Blue Lotus) Flower Extract, Nelumbo Nucifera (Sacred Lotus) Flower Extract, Origanum Vulgare (Oregano) Leaf Extract, Thymus Vulgaris (Thyme) Extract, Cinnamomum Zeylanium (Cinnamon) Bark Extract, Olea Europaea (Olive) Leaf Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sodium Starch Octenylsuccinate, Mentha Piperita (Peppermint) Leaf Extract, Lavandula Angustifolia (Lavender) Flower Extract, Hydrastis Canadensis (Goldenseal) Root Extract, Citrus Limon (Lemon) Peel Extract, Sodium Acrylolydimethyl Taurate Copolymer, Panthenol (Provitamin B5), Sodium Hydroxide, Isohexadecane, Niacinamide (Vitamin B3), Acrylates/C12-22 Alkyl Methacrylate Copolymer, Allantoin, Polysorbate 80, Lysolecithin, Caffeine (from Green Tea), Zinc Hyaluronate, Arbutin, Cocamidopropyl Dimethylamine, Biocomplex2 [Euterpe Oleracea (Acai), [Euterpe Oleracea (Acai), Citrus Limon (Lemon), Malpighia Glabra (Barbados Cherry), Emblica Officinalis (Indian Gooseberry), Adansonia Digitata (Baobab), Myrciaria Dubia (Camu Camu), Daucus Carota Sativa (Carrot), Cocos Nucifera (Coconut) Water, Lycium Barbarum (Goji) Berry, Tapioca Starch (from Cassave Root), Thioctic Acid (Alpha Lipoic Acid) and Ubiquinone (Coenzyme Q10)

*Certified organic ingredient

Acne Advanced Clarifying Hydrator 1.2oz Box (15751-3030-2)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label4Label4

Acne Advanced Clarifying Hydrator 1.2oz Bottle (15751-3030-2)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottle

Acne Advanced Clarifying Hydrator 1.9oz (15751-3030-9)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label5Label5

Acne Advanced Clarifying Hydrator 0.10oz (15751-3030-6)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label00Label00

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
417424salicylic acid 1 % Topical CreamPSN5
417424salicylic acid 10 MG/ML Topical CreamSCD5
417424salicylic acid 1 % Topical CreamSY5

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
e2dae634-14ed-febf-08ee-93196433b5b7Product name920190614
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0a5e5249-329b-0cff-e714-77159f193a87Product name120140508
6b7a6f32-42a6-994d-5ab6-d180e92ee9d8Product name120140508
d394f843-7479-dc48-dbd3-232266c5548cProduct name120140508
dc9a5fb6-14e2-1cc8-a567-a781fd1f0212Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15751-3030-2Acne Advanced Clarifying Hydrator1 in 1 BOXCREAM15
15751-3030-2Acne Advanced Clarifying Hydrator35 mL in 1 BOTTLECREAM355
15751-3030-6Acne Advanced Clarifying Hydrator3 mL in 1 PACKETCREAM35
15751-3030-9Acne Advanced Clarifying Hydrator55 mL in 1 BOTTLECREAM555

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15751-3030ACNE ADVANCED CLARIFYING HYDRATOR (SALICYLIC ACID) CREAM [EMINENCE ORGANIC SKIN CARE LTD.]5Current NDC, Legacy NDC, 4 package rows20231210_b710cc36-f589-4116-a0a2-c6966ebebbf2.zip

Products#

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

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15751-303015751-3030-2, 15751-3030-9, 15751-3030-6

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 44 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOEV5VD430YW9IACT
CUCUMBERYY7C30VXJTIACT
ROSA MOSCHATA OILJ99W255AWFIACT
GRAPEFRUITO82C39RR8CIACT
SYMPHYTUM UPLANDICUM LEAFD05HXK6R3GIACT
PEPPERMINTV95R5KMY2BIACT
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
BETA VULGARIS4G174V5051IACT
GLYCERINPDC6A3C0OXIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARKT7S323PKJSIACT
PROPANEDIOL5965N8W85TIACT
CITRUS MAXIMA FRUIT RIND OIL8U3877WD44IACT
SPEARMINTJ7I2T6IV1NIACT
SODIUM ACRYLATE7C98FKB43HIACT
OREGANO0E5AT8T16UIACT
THYMECW657OBU4NIACT
CINNAMON5S29HWU6QBIACT
OLIVE OIL6UYK2W1W1EIACT
ROSEMARYIJ67X351P9IACT
GOLDENSEALZW3Z11D0JVIACT
LEMON24RS0A988OIACT
DEXPANTHENOL1O6C93RI7ZIACT
SODIUM HYDROXIDE55X04QC32IIACT
ISOHEXADECANE918X1OUF1EIACT
NIACIN2679MF687AIACT
ALLANTOIN344S277G0ZIACT
POLYSORBATE 806OZP39ZG8HIACT
LYSOPHOSPHATIDYLCHOLINE, SOYBEANCQD833204ZIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ARBUTINC5INA23HXFIACT
COCAMIDOPROPYL DIMETHYLAMINEL36BM7DG2TIACT
SOYBEAN OIL241ATL177AIACT
BENZYL ALCOHOLLKG8494WBHIACT
SUNFLOWER OIL3W1JG795YIIACT
SORBIC ACIDX045WJ989BIACT
SODIUM POLYACRYLATE (2500000 MW)05I15JNI2JIACT
ACAI46AM2VJ0AWIACT
CARROTL56Z1JK48BIACT
COCONUT3RT3536DHYIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acne Advanced Clarifying HydratorSALICYLIC ACIDEminence Organic Skin Care Ltd.b710cc36-f589-4116-a0a2-c6966ebebbf22023-12-08WarningsExact identifier
ndc (package): 15751-3030-9
ndc (package): 15751-3030-6
ndc (package): 15751-3030-2
ndc (product): 15751-3030
ndc11 (package): 15751303006
ndc11 (package): 15751303002
ndc11 (package): 15751303009
spl id: 0c0aef9b-7255-0f3d-e063-6394a90aa271
spl set id: b710cc36-f589-4116-a0a2-c6966ebebbf2
Acne Advanced Treatment SystemSALICYLIC ACIDEminence Organic Skin Care Ltd.9acf53a6-10f1-470d-b270-3a0203cf89c02023-12-02WarningsExact identifier
ndc (package): 15751-3030-2
ndc11 (package): 15751303002

Reported adverse events (FAERS/openFDA)#

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