FDA.reportPublic FDA data

Acne Lotion

Manufacturer
Spa de Soleil
Effective date
2026-01-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:34:10

Label at a glance#

ProductAcne Care Lotn
Active ingredientSALICYLIC ACID, SULFUR
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient Purpose

Salicylic Acid (0.5%)..........Acne Treatment

Sulfur (2.0%)......................Acne Treatment

OTC - PURPOSE SECTION

Purpose

Acne Treatment

INDICATIONS & USAGE SECTION

For treatment of acne

WARNINGS SECTION

Warnings

For external use only

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

If swallowed, get medical help or contact a Poison Control Center right away. If excessive skin irritation develops or increases, discontinue use and consult a doctor. Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

OTC - WHEN USING SECTION

When using this product

• Skin irritation and dryness is more likely to occur if you use another topical acne medication while using this product. If irritation occurs, use only one topical acne medication at a time.

DOSAGE & ADMINISTRATION SECTION

Directions

• Clean the skin thoroughly before applying this product • Cover the entire affected area with a thin layer one to three times daily.

• Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three 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.

INACTIVE INGREDIENT SECTION

Other Ingredients:

Aqua, PEG – 100 Stearate, Glyceryl Stearate, Glycerin, Stearic Acid, Cetyl Alcohol, Titanium Dioxide, Butylene Glycol, Carthamus Tinctorius (Safflower) Seed Oil, Zinc Oxide, Hydroxyethyl Cellulose, Sodium Hydroxide, Phenoxyethanol, Ethylhexylglycerin, Chloroxylenol, Tocopheryl Acetate (Vitamin E), Ascorbic Acid (Vitamin C), Malus Domestica (Apple) Fruit Cell Culture Extract, Citric Acid, Lactic Acid, Malic Acid, Gluconic Acid, Glycolic Acid, Salicylic Acid, Tartaric Acid, *CO Alcohol, *CO Glycerin, *CO Salix Alba Bark Extract, *CO Avena Sativa (Oat) Kernel Extract, *CO Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, *CO Pogostemon Cablin Oil, *CO Melaleuca Alternifolia (Tea Tree) Leaf Oil, Disodium EDTA, Sea Salt, **Squalane, Fragrance.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PL Acne Lotion FDAPL Acne Lotion FDA

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68062-2267-12026-01-21C16284748780-12cef2736-69ef-d83d-e063-dadaa90ab31fAcne Lotion
68062-2267-12025-01-30C16284748780-12cef2736-69ef-d83d-e063-dadaa90ab31fAcne Lotion

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68062-2267-1Acne Care Lotn120 mL in 1 BOTTLELOTION1202

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68062-226768062-2267-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
PEG-100 STEARATEYD01N1999RIACT
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
GLYCERINPDC6A3C0OXIACT
SALICYLIC ACIDO414PZ4LPZACTIB
STEARIC ACID D7T3B081197XIACT
CETYL ALCOHOL936JST6JCNIACT
SULFUR70FD1KFU70ACTIB
WATER059QF0KO0RIACT

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
Acne Care LotnSALICYLIC ACIDSpa de Soleil0a90dd85-06d1-13e0-e063-6394a90af2b62026-01-20WarningsExact identifier
ndc (package): 68062-2267-1
ndc (product): 68062-2267
ndc11 (package): 68062226701
spl id: 48df0fc9-fefc-e333-e063-6294a90a977b
spl set id: 0a90dd85-06d1-13e0-e063-6394a90af2b6

Reported adverse events (FAERS/openFDA)#

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