ACNE CARE LOTN- salicylic acid lotion 
Spa de Soleil

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Acne Lotion

Active ingredient Purpose

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

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

Purpose

Acne Treatment

For treatment of acne

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.

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

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.

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.

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.

PL Acne Lotion FDA

ACNE CARE LOTN 
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68062-2267
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1 mg  in 100 mL
SULFUR (UNII: 70FD1KFU70) (SULFUR - UNII:70FD1KFU70) SULFUR2 mg  in 100 mL
Inactive Ingredients
Ingredient NameStrength
PEG-100 STEARATE (UNII: YD01N1999R)  
GLYCERYL STEARATE/PEG-100 STEARATE (UNII: RD25J5V947)  
GLYCERIN (UNII: PDC6A3C0OX)  
STEARIC ACID D7 (UNII: T3B081197X)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68062-2267-1120 mL in 1 BOTTLE; Type 0: Not a Combination Product11/19/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00611/19/2023
Labeler - Spa de Soleil (874682867)
Registrant - Spa de Soleil (874682867)
Establishment
NameAddressID/FEIBusiness Operations
Spa de Soleil874682867manufacture(68062-2267)

Revised: 11/2023
Document Id: 0a90dd85-06d2-13e0-e063-6394a90af2b6
Set id: 0a90dd85-06d1-13e0-e063-6394a90af2b6
Version: 1
Effective Time: 20231120
 
Spa de Soleil