ANTI-AGING DMAE FACE SERUM solution

Anti-Aging DMAE Face Serum by

Drug Labeling and Warnings

Anti-Aging DMAE Face Serum by is a Otc medication manufactured, distributed, or labeled by Gazebo Wellness SKIN LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DOSAGE & ADMINISTRATION

The antioxidants in this serum come from the rich oils of carrot, avocado, rosehip and evening primrose. DMAE serum also contains vitamins and minerals including vitamins A, B, C and E

WARNINGS

Directions: Apply serum to face and neck every morning and/or night. Keeping skin moisturized is important for all skin types. In every step of skin care, always use circular, upward motions with a gentle touch on your face.

INACTIVE INGREDIENT

Inactive ingredients: Glycerin, Emulsifying Wax NF, Phenoxyethanol, Xanthan Gum, Tetrasodium EDTA, Organic Neem Seed Oil.

INDICATIONS & USAGE

Apply serum to face and neck every morning and/or night. Keeping skin moisturized is important for all skin types. In every step of skin care, always use circular, upward motions with a gentle touch on your face.

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children

PURPOSE

SKINBEAUTY
SOLUTION
natural + organic Antioxidant DMAE facial serum
Anti-Aging &
Skin Firming Serum
1 oz/30 ml

ACTIVE INGREDIENT

Active ingredients: Aloe Vera Leaf Juice, Carrot Seed Oil, Avocado Oil, DMAE, Vitamin E, Meadowfoam Seed Oil, Vitamin A, Niacinamide, Vitamin C Ester, Rosehip Fruit Oil, Evening Primrose Oil, Tamanu Oil, Rosemary Leaf Extract.

PRINCIPAL DISPLAY PANEL

Content of labeling

INGREDIENTS AND APPEARANCE

ANTI-AGING DMAE FACE SERUM 
anti-aging dmae face serum solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84785-0055
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
EVENING PRIMROSE OIL (UNII: 3Q9L08K71N) (EVENING PRIMROSE OIL - UNII:3Q9L08K71N)	EVENING PRIMROSE OIL	0.3 mg  in 30 mL
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y) (MEADOWFOAM SEED OIL - UNII:412ZHA4T4Y)	MEADOWFOAM SEED OIL	0.3 mg  in 30 mL
VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	0.3 mg  in 30 mL
AVOCADO OIL (UNII: 6VNO72PFC1) (AVOCADO OIL - UNII:6VNO72PFC1)	AVOCADO OIL	0.3 mg  in 30 mL
CARROT SEED OIL (UNII: 595AO13F11) (CARROT SEED OIL - UNII:595AO13F11)	CARROT SEED OIL	0.3 mg  in 30 mL
TAMANU OIL (UNII: JT3LVK84A1) (TAMANU OIL - UNII:JT3LVK84A1)	TAMANU OIL	0.3 mg  in 30 mL
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	0.3 mg  in 30 mL
ASCORBYL PALMITATE (UNII: QN83US2B0N) (ASCORBYL PALMITATE - UNII:QN83US2B0N)	ASCORBYL PALMITATE	0.3 mg  in 30 mL
ALOE VERA LEAF (UNII: ZY81Z83H0X) (ALOE VERA LEAF - UNII:ZY81Z83H0X)	ALOE VERA LEAF	0.3 mg  in 30 mL
ROSEMARY (UNII: IJ67X351P9) (ROSEMARY - UNII:IJ67X351P9)	ROSEMARY	0.3 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
XANTHAN GUM (UNII: TTV12P4NEE)
TETRASODIUM EDETATE DIHYDRATE (UNII: 3JGX4KKZ4A)
GLYCERIN (UNII: PDC6A3C0OX)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
VITAMIN E POLYETHYLENE GLYCOL SUCCINATE (UNII: O03S90U1F2)	0.3 mg  in 30 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84785-0055-1	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2024
2	NDC: 84785-0055-2	60 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M016	10/01/2024

Labeler - Gazebo Wellness SKIN LLC (119609953)

Registrant - Gazebo Wellness SKIN LLC (119609953)

Establishment
Name	Address	ID/FEI	Business Operations
Gazebo Wellness SKIN LLC		119609953	manufacture(84785-0055)