FDA.reportPublic FDA data

Evereden Botanical Facial Sunscreen SPF 30

Manufacturer
Eden Brands Inc
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:44:59

Label at a glance#

ProductEvereden Botanical Facial Sunscreen SPF 30
Active ingredientZINC OXIDE
Label structure10 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 liberally 15 minutes before sun exposure.  • Reapply at least every 2 hours. • Use a water resistant sunscreen if swimming or sweating • 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 prote...

Label contents#

Full prescribing information#

STATEMENT OF IDENTITY SECTION

Sheer Botanical Facial Sunscreen SPF 30

PrimaryPrimary

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 18.8%

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. 

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - WHEN USING SECTION

When using this product keep out of eyes. Rinse with water to remove.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If 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.
• Use a water resistant sunscreen if swimming or sweating
• 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: 
o Limit your time in the sun, especially from 10a.m. – 2p.m. 
o Wear long-sleeved shirts, pants, hats, and sunglasses. 

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Aqua), Coco-Caprylate/Caprate, Glycerin, Steareth-2, Octyldodecanol, Steareth-21, Propanediol, Cetearyl Alcohol, Polyhydroxystearic Acid, Rosa Centifolia Flower Extract, Zingiber Officinale (Ginger) Root Extract, Helianthus Annuus (Sunflower) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Bisabolol, Cetyl Glyceryl Ether, Sodium Stearoyl Glutamate, Xanthan Gum, Tetrasodium Glutamate Diacetate, Caprylhydroxamic Acid, Sodium Hydroxide

OTHER INFORMATION

OTHER SAFETY INFORMATION

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

RECENT MAJOR CHANGES SECTION

Updated the DIRECTIONS from Section Type "Indications & Usage" to "Dosage & Administration" on 12/2024. No content on the label itself changed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SecondarySecondary

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72113-103-032023-03-15C16284748780-1e4f33bdf-b1f4-d8a0-e053-dadaa90a6e4eBotanical Facial Sunscreen SPF30
72113-103-032022-07-29C16284748780-1e4f33bdf-b1f4-d8a0-e053-dadaa90a6e4eBotanical Facial Sunscreen SPF30

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72113-103EVEREDEN BOTANICAL FACIAL SUNSCREEN SPF 30 (ZINC OXIDE) LOTION [EDEN BRANDS INC]3Legacy NDC20241222_bc977385-fa71-d152-e053-2995a90a4ae2.zip

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
72113-10372113-103-03

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
WATER059QF0KO0RIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
GLYCERINPDC6A3C0OXIACT
STEARETH-2V56DFE46J5IACT
OCTYLDODECANOL461N1O614YIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ROSA CENTIFOLIA FLOWERCS4TE8FF7OIACT
HELIANTHUS ANNUUS WHOLE17S27ZT6KRIACT
SIMMONDSIA CHINENSIS SEEDD24K2Q1F6HIACT
PROPANEDIOL5965N8W85TIACT
ZINGIBER OFFICINALE WHOLEIN6Q3S3414IACT
CETYL GLYCERYL ETHERP9FNL3D0MNIACT
SODIUM STEAROYL GLUTAMATE65A9F4P024IACT
XANTHAN GUMTTV12P4NEEIACT
SODIUM HYDROXIDE55X04QC32IIACT
TETRASODIUM GLUTAMATE DIACETATE5EHL50I4MYIACT
STEARETH-2153J3F32P58IACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT

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
4656751c-1872-10b8-e063-6294a90a6045bc977385-fa71-d152-e053-2995a90a4ae22025-12-19WarningsExact identifier
spl set id: bc977385-fa71-d152-e053-2995a90a4ae2

Reported adverse events (FAERS/openFDA)#

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