AGE BRIGHT SPOT FADER- salicylic acid gel

AGE Bright Spot Fader by

Drug Labeling and Warnings

AGE Bright Spot Fader by is a Otc medication manufactured, distributed, or labeled by Dermalogica, Inc, McKenna Labs, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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

• Apply directly upon first sign of breakout. Reapply twice a day until spot fades.
• If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

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 ℮

INGREDIENTS AND APPEARANCE

AGE BRIGHT SPOT FADER 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68479-806
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68479-806-02	1 in 1 CARTON	06/06/2019
1		15 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 68479-806-00	2 mL in 1 POUCH; Type 0: Not a Combination Product	06/06/2019
3	NDC: 68479-806-01	6 mL in 1 TUBE; Type 0: Not a Combination Product	06/06/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333D	06/06/2019

Labeler - Dermalogica, Inc (177698560)

Establishment
Name	Address	ID/FEI	Business Operations
McKenna Labs, Inc.		090631412	MANUFACTURE(68479-806)