FDA.reportPublic FDA data

PHACE BIOACTIVE CLARIFYING SERUM

Manufacturer
Vara International Inc.
Effective date
2017-02-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:19:53

Label at a glance#

ProductPHACE BIOACTIVE CLARIFYING SERUM
Active ingredientSALICYLIC ACID
Label structure9 sections

Indications and uses

for the treatment of acne reduces the number and severity of acne blemishes and allows skin to heal

Dosage and administration

after cleansing, apply a thin layer to affected area 1-3 times daily.  If irritating dryness or peeling occurs, reduce application to once per day or every other day.

Storage and handling

Store in a cool, dark place.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 1.5%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Uses

INDICATIONS & USAGE SECTION

  • for the treatment of acne
  • reduces the number and severity of acne blemishes and allows skin to heal

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time.  If irritation occurs, only use one topical acne medication at a time.  Avoid eye contact.  If contact occurs, flush thoroughly with water.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

  • after cleansing, apply a thin layer to affected area 1-3 times daily.  If irritating dryness or peeling occurs, reduce application to once per day or every other day.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua/Water/Eau, Arnica Montana Flower Extract, Capryloyl Salicylic Acid, Centella Asiatica Extract, Citric Acid, Cucumis Sativus (Cucumber) Fruit Extract, Curcuma Longa (Turmeric) Root Extract, Diisopropyl Adipate, Glycolic Acid, Hydroxyethylcellulose, Hydroxyethylpiperazine Ethane Sulfonic Acid, Methylisothizolinone, Octadedecenedioic Acid, Polysorbate 80, Alcohol Denat., Sodium Hydroxide, Propanediol, Zingiber Officinale (Ginger) Extract.

Other Information

STORAGE AND HANDLING SECTION

Store in a cool, dark place.

Sunburn Alert:

SPL UNCLASSIFIED SECTION

This product contains an alpha-hydroxy acid (AHA) that may increase your skin's sensitivity to the sun and particularly the possibility of sunburn.  Use a sunscreen, wear protective clothing, and limit sun exposure while using this product and for a week afterwards.

PHACE BIOACTIVE CLARIFYING SERUM 30ml (65121-683-01)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Clarifying Serum LabelClarifying Serum Label

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70960-68370960-683-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
CAPRYLOYL SALICYLIC ACID5F7PJF6AA4IACT
CENTELLA ASIATICA7M867G6T1UIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
CUCUMBERYY7C30VXJTIACT
TURMERIC856YO1Z64FIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
GLYCOLIC ACID0WT12SX38SIACT
HYDROXYETHYLPIPERAZINE ETHANE SULFONIC ACIDRWW266YE9IIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
OCTADECENEDIOIC ACID565ZMT5QRGIACT
POLYSORBATE 806OZP39ZG8HIACT
SODIUM HYDROXIDE55X04QC32IIACT
PROPANEDIOL5965N8W85TIACT
GINGERC5529G5JPQIACT
SALICYLIC ACIDO414PZ4LPZACTIB

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
0749c985-736b-3311-e063-6394a90a800471bf8350-092f-4529-bb6d-2c1fde5d66902023-10-09WarningsExact identifier
spl set id: 71bf8350-092f-4529-bb6d-2c1fde5d6690

Reported adverse events (FAERS/openFDA)#

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