FDA.reportPublic FDA data

Practical Alchemy Hydrating SPF 30

Manufacturer
Over Here, LLC | Southeast Holdings Corp
Effective date
2025-11-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:43:27

Label at a glance#

ProductPractical Alchemy Hydrating SPF 30
Active ingredientZINC OXIDE
Label structure9 sections

Indications and 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.

Dosage and administration

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 su...

Storage and handling

Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

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:

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 14.6%

PURPOSE

OTC - PURPOSE SECTION

Sunscreen

USES:

INDICATIONS & USAGE SECTION

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:

WARNINGS SECTION

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.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

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

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

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)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130850070217019GTIN-13: 0850070217019
EAN-13: 0850070217019
GTIN-12: 850070217019
UPC-A: 850070217019
GTIN storage (14 digits): 00850070217019		Drug Label.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84994-001-02Practical Alchemy Hydrating SPF 3096.4 g in 1 TUBECREAM96.43

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84994-00184994-001-02

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
XANTHAN GUMTTV12P4NEEIACT
SILICAETJ7Z6XBU4IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
GLYCERINPDC6A3C0OXIACT
PULLULAN8ZQ0AYU1TTIACT
ALOE VERA LEAFZY81Z83H0XIACT
SCLEROTIUM GUM2X51AD1X3TIACT
WATER059QF0KO0RIACT
POLYGLYCERYL-6 BEHENATE4T2L7QI313IACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CETYL ALCOHOL936JST6JCNIACT
PROPANEDIOL5965N8W85TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
SHEA BUTTERK49155WL9YIACT
ISOAMYL LAURATEM1SLX00M3MIACT
JOJOBA OIL724GKU717MIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ZINC OXIDESOI2LOH54ZACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-03-07full-release2026-06-01 00:56:49

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Practical Alchemy Hydrating SPF 30ZINC OXIDEOver Here, LLC2f07df5b-dbd4-494c-a7cf-55843fb4d7c22025-11-12WarningsExact identifier
ndc (package): 84994-001-02
ndc (product): 84994-001
ndc11 (package): 84994000102
spl id: 436d97a7-82de-5e3c-e063-6294a90afca9
spl set id: 2f07df5b-dbd4-494c-a7cf-55843fb4d7c2

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.