FDA.reportPublic FDA data

BEAUTY BY EARTH - SPF 20 - UNTINTED

Manufacturer
Pro Skin Solutions, Inc. DBA Active Cosmetics Manufacturing
Effective date
2021-11-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:25:54

Label at a glance#

ProductBEAUTY BY EARTH - SPF 20 - UNTINTED
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 skin aging caused by the sun.

Dosage and administration

Apply generously 15 minutes before sun exposure. Reapply at least every 2 hours or after swimming, towel drying, perspiring heavily, or washing. For children under 6 months of age: Ask a Doctor ​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 a Broad Spectrum SPF value of 15 or higher and other sun pro...

Storage and handling

Protect the product in this container from excessive heat and direct sun.

Label contents#

Full prescribing information#

​Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (Non-nano) 11%

​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 skin 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.

​Stop use and ask a doctor ​if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

​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 generously 15 minutes before sun exposure. Reapply at least every 2 hours or after swimming, towel drying, perspiring heavily, or washing.

For children under 6 months of age: Ask a Doctor

​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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• Limit time in the sun, especially from 10 a.m. - 2 p.m.
• Wear long-sleeved shirts, pants, hats, and sunglasses

​Other information:

STORAGE AND HANDLING SECTION

Protect the product in this container from excessive heat and direct sun.

​Inactive Ingredients

INACTIVE INGREDIENT SECTION

*Aloe Barbadensis (Aloe Vera) Leaf Juice, *Cocos Nucifera (Coconut) Oil, Sorbitan Sesquioleate, *Glycerin (Vegetable), Glyceryl Stearate SE, *Helianthus Annuus (Sunflower) Oil, *Simmondsia Chinensis (Jojoba) Seed Oil, *Ricinus Communis (Castor) Seed Oil, *Rosmarinus Officinalis Leaf Extract, Magnesium Sulfate, Ascorbyl Glucoside (Vitamin C), Xanthan Gum, *Argania Spinosa Kernel (Argan) Oil, *Cucumis Sativus (Cucumber) Fruit Extract, *Ginkgo Biloba Extract, Radish Root Ferment Filtrate, Cupressus Sempervirens (Cypress) Leaf Essential Oil, Citrus Paradisi (Pink Grapefruit) Essential Oil
*Certified Organic Ingredients

SPL UNCLASSIFIED SECTION

Facial Sunscreen

Mineral Sunscreen for Daily Use

Water Resistant 80 Minutes

​For All Skin Types

​VEGAN INGREDIENTS

inspire beauty, naturally

Our mineral sunscreen sits on top of your skin forming a protective barrier, without added harmful ingredients. It's safe for you and the environment so use whenever and wherever!

Manufactured for and distributed by:
Beauty by Earth • Flower Mound, TX 75028
www.beautybyearth.com

© Beauty by Earth. All rights reserved.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15464-001215464-0012-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
ALOE VERA LEAFZY81Z83H0XIACT
COCONUT OILQ9L0O73W7LIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
SUNFLOWER OIL3W1JG795YIIACT
JOJOBA OIL724GKU717MIACT
CASTOR OILD5340Y2I9GIACT
ROSEMARYIJ67X351P9IACT
MAGNESIUM SULFATE, UNSPECIFIED FORMDE08037SABIACT
ASCORBYL GLUCOSIDE2V52R0NHXWIACT
XANTHAN GUMTTV12P4NEEIACT
ARGAN OIL4V59G5UW9XIACT
CUCUMBERYY7C30VXJTIACT
GINKGO19FUJ2C58TIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
CUPRESSUS SEMPERVIRENS LEAF OILM7QUY89S4OIACT
GRAPEFRUIT OILYR377U58W9IACT

Source Document#

Source XML

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
48d14e98-19d6-4e55-9f75-a83495713cf81a08f6a2-277f-445a-a13d-8944f9495c312021-11-19WarningsExact identifier
spl id: 48d14e98-19d6-4e55-9f75-a83495713cf8
spl set id: 1a08f6a2-277f-445a-a13d-8944f9495c31

Reported adverse events (FAERS/openFDA)#

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