AGE BRIGHT SPOT FADER- salicylic acid gel 
Dermalogica, 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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AGE Bright Spot Fader

Drug Facts

Active Ingredient

Salicylic Acid (2.0%)

Purpose

Acne treatment

Indications

For the treatment of acne

Warnings

For external use only

When using this product

  • Skin irritation and dryness are more likely to occur if you use another topical acne medication at the same time. If irritation occurs, only use one topical acne medication at a time.

Keep out of reach of children.

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

Directions

Inactive Ingredients

Water/Aqua/Eau, Butylene Glycol, Hamamelis Virginiana (Witch Hazel) Water, Isopropyl Lauroyl Sarcosinate, Niacinamide, Propanediol, Polyacrylate Crosspolymer-6, Caprylyl Methicone, Glycereth-26, Saccharide Isomerate, Hexylresorcinol, Salvia Sclarea (Clary) Oil, Malic Acid, Aloe Barbadensis Extract, Salvia Sclarea (Clary) Extract, Lavandula Angustifolia (Lavender) Oil, Citrus Limon (Lemon) Peel Oil, Rosmarinus Officinalis (Rosemary) Leaf Oil, Lavandula Hybrida Oil, Sclerotium Gum, Sodium Carrageenan, Thymol, Terpineol, Pullulan, Lecithin, Glycerin, Dimethyl Isosorbide, PEG-12 Dimethicone/PPG-20 Crosspolymer, Xanthan Gum, Sodium Citrate, Ethylhexylglycerin, Tetrasodium Glutamate Diacetate, Silica, Tocopherol, Sea Salt, Potassium Sorbate, Sodium Benzoate, Sodium Hydroxide, Citric Acid, Benzoic Acid, Aminomethyl Propanol, Phenoxyethanol.

Questions or comments

Call toll free 1-800-831-5150 in the US.

PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton

NEW

brightening
spot
treatment

Active Clearing

0.5 US FL OZ / 15 mL ℮

PRINCIPAL DISPLAY PANEL - 15 mL Tube Carton
AGE BRIGHT SPOT FADER 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68479-806
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Butylene Glycol (UNII: 3XUS85K0RA)  
HAMAMELIS VIRGINIANA TOP WATER (UNII: NT00Y05A2V)  
Isopropyl Lauroyl Sarcosinate (UNII: LYR06W430J)  
Niacinamide (UNII: 25X51I8RD4)  
Propanediol (UNII: 5965N8W85T)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)  
Glycereth-26 (UNII: NNE56F2N14)  
Saccharide Isomerate (UNII: W8K377W98I)  
Hexylresorcinol (UNII: R9QTB5E82N)  
CLARY SAGE OIL (UNII: 87L0D4U3M0)  
Malic Acid (UNII: 817L1N4CKP)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
LAVENDER OIL (UNII: ZBP1YXW0H8)  
LEMON OIL (UNII: I9GRO824LL)  
ROSEMARY OIL (UNII: 8LGU7VM393)  
LAVANDIN OIL (UNII: 9RES347CKG)  
BETASIZOFIRAN (UNII: 2X51AD1X3T)  
CARRAGEENAN SODIUM (UNII: 7CY8BVL34N)  
Thymol (UNII: 3J50XA376E)  
Terpineol (UNII: R53Q4ZWC99)  
Pullulan (UNII: 8ZQ0AYU1TT)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
Glycerin (UNII: PDC6A3C0OX)  
Dimethyl Isosorbide (UNII: SA6A6V432S)  
PEG-12 Dimethicone/PPG-20 Crosspolymer (UNII: 965K72OQXO)  
Xanthan Gum (UNII: TTV12P4NEE)  
SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR)  
Ethylhexylglycerin (UNII: 147D247K3P)  
Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
Tocopherol (UNII: R0ZB2556P8)  
Sea Salt (UNII: 87GE52P74G)  
Potassium Sorbate (UNII: 1VPU26JZZ4)  
Sodium Benzoate (UNII: OJ245FE5EU)  
Sodium Hydroxide (UNII: 55X04QC32I)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
Benzoic Acid (UNII: 8SKN0B0MIM)  
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68479-806-021 in 1 CARTON06/06/2019
115 mL in 1 TUBE; Type 0: Not a Combination Product
2NDC:68479-806-002 mL in 1 POUCH; Type 0: Not a Combination Product06/06/2019
3NDC:68479-806-016 mL in 1 TUBE; Type 0: Not a Combination Product06/06/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333D06/06/2019
Labeler - Dermalogica, Inc (177698560)
Establishment
NameAddressID/FEIBusiness Operations
McKenna Labs, Inc.090631412MANUFACTURE(68479-806)

Revised: 7/2019
Document Id: 1ca5355a-a337-4491-99cc-3e93cfc278a9
Set id: 09659a5b-5fb7-4346-bce6-fa03ca400c1e
Version: 1
Effective Time: 20190718
 
Dermalogica, Inc