Initial Drug Listing - BellamiLuxx Butt Acne Treatment Cream

BellamiLuxx Butt Acne Treatment Cream by

Drug Labeling and Warnings

BellamiLuxx Butt Acne Treatment Cream by is a Otc medication manufactured, distributed, or labeled by BellamiLuxx LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BELLAMILUXX BUTT ACNE TREATMENT CREAM- salicylic acid 2% cream 
BellamiLuxx LLC

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Initial Drug Listing - BellamiLuxx Butt Acne Treatment Cream

Salicylic Acid 2%

Acne treatment

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

For external use only.

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

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

• 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 asdirected by a doctor.
• lf bothersome dryness or peeling occurs, reduce application to once a day or every other day.

Water, Propylene Glycol, Butylene Glycol, Glycerin,Cetearyl Alcohol, lsononyl lsononanoate,Dimethicone, PEG/PPG-14/7 Dimethyl Ether,Triethylhexanoin, Steareth-21, Aminomethyl Propanol, Steareth-2,Polyacrylate-13,PEG-100Stearate, Glyceryl Stearate, Polyisobutene,Phenoxyethanol, Hamamelis Virginiana (WitchHazel) Water, Xanthan Gum, Polyacrylate Crosspolymer-6, Methylparaben, Lactobacillus/Soymilk Femment Filtrate, Bisabolol, Allantoin,Niacinamide, Melaleuca Altemifolia (Tea Tree) Leaf Oil, Hydroxydecyi Ubiquinone, Pentylene Glycol,Hamamelis Virginiana (Witch Hazel) Extract,Hydrolyzed Hyaluronic Acid, Hydroxypropyltrimonium Hyaluronate, Sodium Acetylated Hyaluronate,Hyaluronic Acid, Sodium Hyaluronate Crosspolymer, Hydrolyzed Sodium Hyaluronate,Potassium Hyaluronate, Chondrus Crispus Extract,Ceramide EOP, Ceramide AP, Sodium Hyaluronate,Ceramide NS/Ceramide NG, Ceramide AS,Hydrogenated Lecithin, Ceramide NP, Polysorbate20,1,2-Hexanediol, Hydroxyacetophenone,Sorbitan lsostearate, Disodium EDTA, CaprylylGlycol, Glucose.

• Email: service@bellamiluxx.com
• Visit: www.bellamiluxx.com

BELLAMILUXX BUTT ACNE TREATMENT CREAM 
salicylic acid 2% cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 87205-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GLYCERIN (UNII: PDC6A3C0OX)
POLYISOBUTYLENE (55000 MW) (UNII: TQ77WR8A02)
GLUCOSE (UNII: 5SL0G7R0OK)
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)
BISABOLOL (UNII: 24WE03BX2T)
CERAMIDE NP (UNII: 4370DF050B)
SODIUM ACETYLATED HYALURONATE (UNII: WN66R7GL93)
CERAMIDE NG (UNII: C04977SRJ5)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
TRIETHYLHEXANOIN (UNII: 7K3W1BIU6K)
AMINOMETHYL PROPANOL (UNII: LU49E6626Q)
HYDROXYDECYL UBIQUINONE (UNII: HB6PN45W4J)
NIACINAMIDE (UNII: 25X51I8RD4)
XANTHAN GUM (UNII: TTV12P4NEE)
HAMAMELIS VIRGINIANA LEAF (UNII: T07U1161SV)
HYDROGENATED SOYBEAN LECITHIN (UNII: H1109Z9J4N)
POLYACRYLATE CROSSPOLYMER-6 (UNII: Q7UI015FF9)
LACTOBACILLUS (UNII: 5307V7XW8I)
PEG-9 DIGLYCIDYL ETHER/SODIUM HYALURONATE CROSSPOLYMER (UNII: 788QAG3W8A)
DIMETHICONE 6 (UNII: RB8V8W9FQN)
PEG-100 STEARATE (UNII: YD01N1999R)
METHYLPARABEN (UNII: A2I8C7HI9T)
EDETATE DISODIUM (UNII: 7FLD91C86K)
PEG/PPG-14/7 DIMETHYL ETHER (UNII: 6DNW9T7YT2)
POLYACRYLATE-13 (UNII: FS2D4T67EA)
WATER (UNII: 059QF0KO0R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
HYALURONIC ACID (UNII: S270N0TRQY)
CERAMIDE EOS (UNII: CR0J8RN66K)
CERAMIDE AP (UNII: F1X8L2B00J)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4)
ALLANTOIN (UNII: 344S277G0Z)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
STEARETH-21 (UNII: 53J3F32P58)
STEARETH-2 (UNII: V56DFE46J5)
HYALURONATE SODIUM (UNII: YSE9PPT4TH)
MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL (UNII: VIF565UC2G)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 87205-001-01	100 g in 1 CARTON; Type 0: Not a Combination Product	11/27/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	11/27/2025	12/01/2025

Labeler - BellamiLuxx LLC (126895673)

Registrant - BellamiLuxx LLC (126895673)

Revised: 12/2025

Document Id: 46aed67d-c30b-4d22-e063-6394a90abf19

34390-5

Set id: 42f3367f-40a2-5d97-e063-6294a90a6e33

Version: 2

Effective Time: 20251224