FDA.reportPublic FDA data

Initial Drug Listing - BellamiLuxx Cystic Acne Treatment Lotion

Manufacturer
BellamiLuxx LLC
Effective date
2025-12-24
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:34:12

Label at a glance#

ProductBellamiLuxx Cystic Acne Treatment Lotions
Active ingredientSALICYLIC ACID
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid 2%

OTC - PURPOSE SECTION

Acne treatment

DOSAGE & ADMINISTRATION SECTION

  • For the treatment of acne.
  • Penetrates pores to eliminate mostacne blemishes, blackheads and whiteheads.
  • Helps prevent new acne blemishes, blackheads and whiteheads.

WARNINGS SECTION

For external use only.

OTC - WHEN USING SECTION

skin irritation and dryness is more likely to occur if you use another topical acnemedication at the same time. lf irritation occurs, only use one topical acne medication at a time.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

lf swallowed, get medical help or contact a Poison Control Center rightaway.

INDICATIONS & USAGE SECTION

  • 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 theskin 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

Aqua (Water), Propylene Glycol,Butylene Glycol, Glycerin, Cetearyl, Alcohol. Dimethicone, lsononyl Isononanoate,Centella Asiatica Leaf Extract, Triethylhexanoin, PEG/PPG-14/7 Dimethyl Ether,Steareth-21, Aminomethyl Propanol,Steareth-2, Polyacrylate-13,
1,2-Hexanediol, Hydroxyacetophe-none, Glyceryl Stearate, PEG-100Stearate,Panthenol,Polyisobutene.Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Madecassoside, Sophora Flavescens Root Extract,Tocopheryl Acetate, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Niacinamide, Allantoin, Trehalose,Centella Asiatica Extract, Polysorbate20, Ophiopogon Japonicus Root Extract, Opuntia Ficus-Indica Stem Extract, Hamamelis Virginiana (WitchHazel) Extract, Xanthan Gum, Tribulus Terrestris Fruit Extract. Hydroxydecyl Ubiquinone. Asiaticoside, Cornus Officinalis Fruit Extract, Disodium EDTA, Caprylyl Glycol, Pentylene Glycol, Pandanus Amaryllifolius Leaf Extract.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

packagepackage

Products#

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

DailyMed product names page 1 of 2 · 46 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87205-00287205-002-01

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
DIMETHICONE92RU3N3Y1OIACT
POLYISOBUTYLENE (55000 MW)TQ77WR8A02IACT
STEARETH-2V56DFE46J5IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
HAMAMELIS VIRGINIANA (WITCH HAZEL) LEAF WATER8FP93ED6H2IACT
OPUNTIA FICUS-INDICA STEMMUD8892KHLIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
BUTYLENE GLYCOL3XUS85K0RAIACT
STEARETH-2153J3F32P58IACT
PANTHENOLWV9CM0O67ZIACT
EDETATE DISODIUM7FLD91C86KIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
CENTELLA ASIATICA LEAF WATERC4TH45M3K8IACT
TRIETHYLHEXANOIN7K3W1BIU6KIACT
GLYCERINPDC6A3C0OXIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
POLYACRYLATE-13FS2D4T67EAIACT
AQUA059QF0KO0RIACT
OPHIOPOGON JAPONICUS ROOT90PS6JV9GZIACT
AMINOMETHYL PROPANOLLU49E6626QIACT
CAPRYLYL GLYCOL00YIU5438UIACT
HYDROXYACETOPHENONEG1L3HT4CMHIACT
HYDROXYDECYL UBIQUINONEHB6PN45W4JIACT
POLYSORBATE 207T1F30V5YHIACT
XANTHAN GUMTTV12P4NEEIACT
CORNUS OFFICINALIS FRUIT23NL8NQ187IACT
CETEARETH-20YRC528SWUYIACT
PEG/PPG-14/7 DIMETHYL ETHER6DNW9T7YT2IACT
PENTYLENE GLYCOL50C1307PZGIACT
TREHALOSEB8WCK70T7IIACT
ASIATICOSIDEPKO39VY215IACT
PANDANUS AMARYLLIFOLIUS LEAF7TVT2CK45VIACT
PEG-100 STEARATEYD01N1999RIACT
MADECASSOSIDECQ2F5O6YIYIACT
SOPHORA FLAVESCENS ROOTIYR6K8KQ5KIACT
SALICYLIC ACIDO414PZ4LPZACTIB
GLYCERYL STEARATE230OU9XXE4IACT
ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S)8Z5ZAL5H3VIACT
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OILVIF565UC2GIACT
ALCOHOL3K9958V90MIACT

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
46bd65e2-6e8e-e39e-e063-6294a90adcf1469ad2a5-e97f-1820-e063-6294a90a89702025-12-24WarningsExact identifier
spl id: 46bd65e2-6e8e-e39e-e063-6294a90adcf1
spl set id: 469ad2a5-e97f-1820-e063-6294a90a8970

Reported adverse events (FAERS/openFDA)#

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