SALICYLACNE-2% CLEARING SERUM- salicylic acid liquid 
Valley of the Sun Cosmetics LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Salicylacne-2% Clearing Serum

Active Ingredients

Salicylic Acid 2%

Purpose

Acne Treatment

Uses

Use for treatment of acne

Warning

For external use only

Do not use

Allergy Alert: Do not use this product if you have a known allergy to salicylic acid.

When using this product

Skin irritation and dryness is more likely 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 contact with eyes. If contact occurs, flush thoroughly with water.

Stop use and ask doctor

If irritation or sensitivity occurs, stop use of product and consult doctor.

Keep out of reach of children

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

Directions

Clean the skin thoroughly before applying this product. Apply affected area with a thin layer, avoiding eye area. Allow to absorb before applying additional products. Can be used twice daily or as directed by a doctor.

Inactive ingredients

Water (aqua), vegetable (kosher) glycerin, propylene glycol (kosher), alcohol, retinol (vitamin A), tocopheryl acetate (vitamin E), azelaic acid, gluthathione, lactic acid, sodium ascorbyl phosphate (Vitamin C), carica papaya (papaya) fruit extract, citrus paradise (*organic grapefruit) fruit extract, citrus medica limonum (*organic lemon) extract, bromelain (*pineapple stem leaf), sulfur, sodium PCA, PPG-5-Ceteth-20, PEG-40 hydrogenated (castor oil), potassium sorbate, phenoxyethanol, hydroxyethylcellulose, carbomer, citric acid, sodium hydroxide

Label

Label

SALICYLACNE-2% CLEARING SERUM 
salicylic acid liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76523-020
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID2 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M)  
VITAMIN A (UNII: 81G40H8B0T)  
LACTIC ACID (UNII: 33X04XA5AT)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
CARICA PAPAYA WHOLE (UNII: S0U63B0Q51)  
CITRUS PARADISI WHOLE (UNII: 3FNT9K2294)  
STEM BROMELAIN (UNII: ZLM4P8929R)  
TECHNETIUM TC-99M SULFUR COLLOID (UNII: 556Q0P6PB1)  
PPG-5-CETETH-20 (UNII: 4AAN25P8P4)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
AZELAIC ACID (UNII: F2VW3D43YT)  
CITRUS MEDICA FRUIT (UNII: ZE5Q6PN9ON)  
PEG-40 CASTOR OIL (UNII: 4ERD2076EF)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
1-PALMITOYL-2-OLEOYL-SN-GLYCERO-3-(PHOSPHO-RAC-(1-GLYCEROL)), SODIUM SALT (UNII: T52TI8BMQ6)  
CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
GLYCERIN (UNII: PDC6A3C0OX)  
3-HEXYLOXYPROPYLENE GLYCOL (UNII: 3485P35DA4)  
GLUTATHIONE (UNII: GAN16C9B8O)  
Product Characteristics
ColorgrayScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76523-020-3030 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product01/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D01/01/2021
Labeler - Valley of the Sun Cosmetics LLC (176470664)
Registrant - Valley of the Sun Cosmetics LLC (176470664)
Establishment
NameAddressID/FEIBusiness Operations
Valley of the Sun Cosmetics LLC176470664manufacture(76523-020)

Revised: 6/2021
Document Id: c4e802eb-b9a2-55af-e053-2995a90a4ee5
Set id: c4e802eb-b9a1-55af-e053-2995a90a4ee5
Version: 1
Effective Time: 20210616
 
Valley of the Sun Cosmetics LLC