PRACTICAL ALCHEMY HYDRATING SPF 30- zinc oxide cream

Practical Alchemy Hydrating SPF 30 by

Drug Labeling and Warnings

Practical Alchemy Hydrating SPF 30 by is a Otc medication manufactured, distributed, or labeled by Over Here, LLC, Southeast Holdings Corp. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

HYDRATING SPF 30

Water Resistant and Broad Spectrum

Crafted with a gentle blend of tailored ingredients for sensitive skin. Infused with skin-loving ingredients like Aloe, Green Tea, and Jojoba Oil, this SPF 30 moisturizer offers daily protection against the sun's harmful rays.

FORMULATED WITH

ALOE BARBADENSIS (Aloe Vera) LEAF EXTRACT

JOJOBA OIL

SHEA BUTTER

GREEN TEA (Camellia Sinensis) LEAF EXTRACT

DRUG FACTS ACTIVE INGREDIENTS:

Zinc Oxide 14.6%

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.

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.

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)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

PRACTICAL ALCHEMY HYDRATING SPF 30 
zinc oxide cream

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 84994-001-02	96.4 g in 1 TUBE; Type 0: Not a Combination Product	03/07/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	03/07/2025

Labeler - Over Here, LLC (112602028)

Establishment
Name	Address	ID/FEI	Business Operations
Southeast Holdings Corp		080504027	manufacture(84994-001)