PRACTICAL ALCHEMY PURIFY AND PROTECT DUO- micellar water wipes and zinc oxide kit

Practical Alchemy Purify and Protect Duo by

Drug Labeling and Warnings

Practical Alchemy Purify and Protect Duo by is a Otc medication manufactured, distributed, or labeled by Over Here, LLC, A.I.G. TECHNOLOGIES, INC., JP Packaging LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS:

Zinc Oxide 14.6%

WARNINGS:

For external use only Do not use on damaged or broken skin when using this product Keep out of eyes. Rinse with water to remove Keep out of reach of children If product is swallowed, get medical help or contact a Poison Control Center right away.

PURPOSE

Sunscreen

USES:

Helps prevent sunburn If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early aging caused by the sun.

KEEP OUT OF REACH OF CHILDREN

DIRECTIONS:

Apply liberally 15 minutes before sun exposure Reapply at least every 2 hours and immediately upon towel drying after 80 minutes of swimming or sweating. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from 10 a.m. - 2 pm Wear long sleeve shirts, pants, hats, and sunglasses Children under 6 months: Ask a doctor.

OTHER INFORMATION

Protect this product from excessive heat and direct sun.

INACTIVE INGREDIENTS

Water, Coco-Caprylate/Caprate, Isoamyl Laurate, Glycerin, Propanediol, Shea (Butyrospermum Parkii) Butter, Jojoba (Simmondsia Chinensis) Seed Oil, Polyglyceryl-6 Stearate, Polyglycerl-6 Behenate, Aloe Barbadensis Leaf Extract, Green Tea (Camellia Sinensis) Leaf Extract,Sphingomonas Ferment Extract, Pongomia Pinnata Seed Extract, Xanthan Gum, Cetyl Alcohol, Silica, Lecithin, Sclerotium Gum, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Pullulan, Phenoxyethanol, Ethylhexylglycerin, Fragrance (Parfum)

Representative Images of Cosmetic Product and Drug Product Parts

Cosmetic Part

Drug Part

INGREDIENTS AND APPEARANCE

PRACTICAL ALCHEMY PURIFY AND PROTECT DUO 
micellar water wipes and zinc oxide kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 84994-002

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84994-002-01	1 in 1 CARTON; Type 1: Convenience Kit of Co-Package	02/24/2025

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 POUCH	1
Part 2	1 PACKET	4.5 g

Part 1 of 2

PRACTICAL ALCHEMY PURIFYING 
disposable wipes [personal cleanliness] cloth

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	POLYGLYCERYL-6 CAPRYLATE (UNII: DGV8R54VG7)
INGR	PHENOXYETHANOL (UNII: HIE492ZZ3T)
INGR	POLYGLYCERYL-4 CAPRATE (UNII: 3N873UN885)
INGR	POLYGLYCERYL-6 RICINOLEATE (UNII: 8X57R183N7)
INGR	LINALOOL (UNII: D81QY6I88E)
INGR	ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
INGR	WATER (UNII: 059QF0KO0R)
INGR	CITRIC ACID (UNII: 2968PHW8QP)
INGR	AVOCADO OIL (UNII: 6VNO72PFC1)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		1 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Cosmetic		02/24/2025

Part 2 of 2

PRACTICAL ALCHEMY HYDRATING SPF 30 
zinc oxide cream

Product Information
Item Code (Source)	NDC: 84994-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	14.6 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
SCLEROTIUM GUM (UNII: 2X51AD1X3T)
SILICA (UNII: ETJ7Z6XBU4)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
PULLULAN (UNII: 8ZQ0AYU1TT)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CETYL ALCOHOL (UNII: 936JST6JCN)
WATER (UNII: 059QF0KO0R)
ISOAMYL LAURATE (UNII: M1SLX00M3M)
JOJOBA OIL (UNII: 724GKU717M)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
PROPANEDIOL (UNII: 5965N8W85T)
POLYGLYCERYL-6 BEHENATE (UNII: 4T2L7QI313)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
GLYCERIN (UNII: PDC6A3C0OX)
SHEA BUTTER (UNII: K49155WL9Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)
XANTHAN GUM (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84994-001-01	4.5 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/24/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	02/24/2025

Labeler - Over Here, LLC (112602028)

Establishment
Name	Address	ID/FEI	Business Operations
A.I.G. TECHNOLOGIES, INC.		086365223	manufacture(84994-001)

Establishment
Name	Address	ID/FEI	Business Operations
JP Packaging LLC		151369456	label(84994-002) , pack(84994-002)