DUAL EFFECTS MOISTURIZER- salicylic acid lotion 
Fruit of the Earth, Inc.

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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SPACOLOGY DUAL EFFECTS MOISTURIZER

Active Ingredient

Salicylic Acid 0.25%

Purpose

Acne Medication

Uses

Warnings

For external use only

When using this product

Keep out of reach of children

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

Directions

Other information

Inactive ingredients

Water, Dicaprylyl Ether, Glycerin, Cetearyl Alcohol, Dimethicone, Neopentyl Glycol Diisostearate, Neopentyl Glycol Diethylhexanoate, Aluminum Starch Octenylsuccinate, Methyl Gluceth-20, Dicetyl Phosphate, Ceteth-10 Phosphate, Mentyl Lacatate, Steareth-21, Steareth-2, Fragrance, Xanthan Gum, Disodium EDTA, Sodium Hydroxide, Magnesium Aluminum Silicate, BHT.

Label

Spacology Dual Effects Moisturizer

4 fl oz (118 mL)

NDC 62217-158-04

SP29015EF

DUAL EFFECTS MOISTURIZER 
salicylic acid lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62217-158
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYL GLUCETH-20 (UNII: J3QD0LD11P)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
XANTHAN GUM (UNII: TTV12P4NEE)  
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)  
CETETH-10 PHOSPHATE (UNII: 4E05O5N49G)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
NEOPENTYL GLYCOL DIISOSTEARATE (UNII: 4M6OQ34JWW)  
NEOPENTYL GLYCOL DIETHYLHEXANOATE (UNII: U68ZV6W62C)  
STEARETH-2 (UNII: V56DFE46J5)  
STEARETH-21 (UNII: 53J3F32P58)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
DICAPRYLYL ETHER (UNII: 77JZM5516Z)  
MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62217-158-04118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product11/15/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333D11/15/2017
Labeler - Fruit of the Earth, Inc. (079559467)

Revised: 2/2021
Document Id: bafe63ab-7751-9554-e053-2a95a90a0f51
Set id: 484f5c0f-9925-4c9f-b25c-499a01a0e3c8
Version: 4
Effective Time: 20210210
 
Fruit of the Earth, Inc.