RETINOL PLUS AHA CREAM solution

Retinol plus AHA Cream by

Drug Labeling and Warnings

Retinol plus AHA Cream 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

SKINBEAUTY
SOLUTIONS
natural + organic AHA+Vitamin A Cream
with 1,700,000 IU/g
Formulated with Vitamin A, Alpha Hydroxy Acid, Multi-Fruit Acid, Vitamins and Minerals.

WARNINGS

Limit initial use to once or twice a week; gradually increase frequency to every other night, and finally each evening as tolerated. Apply AHA+Vitamin A Cream to thoroughly cleansed skin in the evening. Carefully avoid the eyes and the corners of the eyes. To ensure optimal results, wait at least 30 minutes before applying any corrective or moisturizing products.

INACTIVE INGREDIENT

Inactive ingredients: Emulsifying Wax, Palm Stearic Acid, Vegetable Glycerin, Phenoxyethanol, Xanthan Gum, Tetrasodium EDTA.

INDICATIONS & USAGE

Directions: Limit initial use to once or twice a week; gradually increase frequency to every other night, and finally each evening as tolerated. Apply AHA+Vitamin A Cream to thoroughly cleansed skin in the evening. Carefully avoid the eyes and the corners of the eyes. To ensure optimal results, wait at least 30 minutes before applying any corrective or moisturizing products.

KEEP OUT OF REACH OF CHILDREN

keep out of reach of children

PURPOSE

natural + organic AHA+Vitamin A Cream
with 1,700,000 IU/g
Formulated with Vitamin A, Alpha Hydroxy Acid, Multi-Fruit Acid, Vitamins and Minerals.
Distributed By:
Skin Beauty Solutions Elk Grove CA 95759

ACTIVE INGREDIENT

Active ingredients: Organic Aloe Juice, Organic Aloe Butter, Apricot Kernel Oil, Organic Seaweed Extract, Organic Green Tea Extract, Organic Bilberry Extract, Organic Sugar Cane Extract, Organic Sugar Maple Extract, Organic Orange Extract, Organic Lemon Extract, Organic Cranberry Extract, Vitamin E, Glycolic Acid, Tartaric Acid, Malic Acid, Mango, Retinol, Mango Butter, Shea Butter, Willow Bark Extract, Neem Oil, Rosemary Extract.

PRINCIPAL DISPLAY PANEL

Content of labeling

INGREDIENTS AND APPEARANCE

RETINOL PLUS AHA CREAM 
retinol plus aha cream solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84785-0008
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CRANBERRY SEED (UNII: 38ZFO1X2U7) (CRANBERRY SEED - UNII:38ZFO1X2U7)	CRANBERRY SEED	0.3 mg  in 30 mL
WILLOW BARK (UNII: S883J9JDYX) (WILLOW BARK - UNII:S883J9JDYX)	WILLOW BARK	0.3 mg  in 30 mL
GREEN TEA LEAF (UNII: W2ZU1RY8B0) (GREEN TEA LEAF - UNII:W2ZU1RY8B0)	GREEN TEA LEAF	0.3 mg  in 30 mL
MANGO (UNII: I629I3NR86) (MANGO - UNII:I629I3NR86)	MANGO	0.3 mg  in 30 mL
SHEA BUTTER (UNII: K49155WL9Y) (SHEA BUTTER - UNII:K49155WL9Y)	SHEA BUTTER	0.3 mg  in 30 mL
ROSEMARY (UNII: IJ67X351P9) (ROSEMARY - UNII:IJ67X351P9)	ROSEMARY	0.3 mg  in 30 mL
APRICOT KERNEL OIL (UNII: 54JB35T06A) (APRICOT KERNEL OIL - UNII:54JB35T06A)	APRICOT KERNEL OIL	0.3 mg  in 30 mL
GLYCOLIC ACID (UNII: 0WT12SX38S) (GLYCOLIC ACID - UNII:0WT12SX38S)	GLYCOLIC ACID	0.3 mg  in 30 mL
ORANGE JUICE (UNII: 5A9KE2L9L3) (ORANGE JUICE - UNII:5A9KE2L9L3)	ORANGE JUICE	0.3 mg  in 30 mL
LEMON (UNII: 24RS0A988O) (LEMON - UNII:24RS0A988O)	LEMON	0.3 mg  in 30 mL
MALIC ACID (UNII: 817L1N4CKP) (MALIC ACID - UNII:817L1N4CKP)	MALIC ACID	0.3 mg  in 30 mL
TARTARIC ACID (UNII: W4888I119H) (TARTARIC ACID - UNII:W4888I119H)	TARTARIC ACID	0.3 mg  in 30 mL
RETINOL (UNII: G2SH0XKK91) (RETINOL - UNII:G2SH0XKK91)	RETINOL	0.3 mg  in 30 mL
BILBERRY JUICE (UNII: 3CCB416HVP) (BILBERRY JUICE - UNII:3CCB416HVP)	BILBERRY JUICE	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

Inactive Ingredients
Ingredient Name	Strength
STEARIC ACID (UNII: 4ELV7Z65AP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
VITAMIN E POLYETHYLENE GLYCOL SUCCINATE (UNII: O03S90U1F2)
XANTHAN GUM (UNII: TTV12P4NEE)
TETRASODIUM EDETATE DIHYDRATE (UNII: 3JGX4KKZ4A)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84785-0008-1	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2024
2	NDC: 84785-0008-2	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(84785-0008)