FDA.reportPublic FDA data

ZINC OXIDE

Manufacturer
Leiluna LLC | Island Kinetics, Inc. d.b.a. CoValence Laboratories
Effective date
2019-04-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:59:23

Label at a glance#

ProductTreeActiv Safflower Oleosomes Daily Natural Moisturizing Sunscreen Broad Spectrum SPF 30
Active ingredientZINC OXIDE
Label structure11 sections

Dosage and administration

Apply liberally and evenly 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours. Sun Protections Measures. Spending time in the sun increases our risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including: limiting time in the sun espe...

Storage and handling

Protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 13%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Use(s)

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 - WHEN USING SECTION

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

OTC - STOP USE SECTION

  • Stop use and ask a doctor if rash occurs

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 and evenly 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours.
  • Sun Protections Measures. Spending time in the sun increases our risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 15 or higher and other sun protection measures including:
    • limiting time in the sun especially from 10:00a.m. - 2:00 p.m.
    • wear long-sleeve shirts, pants, hats, and sunglasses.

Chidren under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), C12-15 Alkyl Benzoate, Carthamus Tinctorius (Safflower) Oleosomes, Polysorbate 60, Cetyl Alcohol, Glycerin, Helianthus Annuus (Sunflower) Seed Oil1, Cetearyl Alcohol, Coco-Glucoside, Caprylic/Capric Triglyceride, Leuconostoc/Radish Root Ferment Filtrate, Isostearic Acid, Sclerotium Gum, Caprylyl Glycol, Polyhydroxystearic Acid, Phytic Acid, Xanthan Gum, Hamamelis Virginiana (Witch Hazel) Water, Citric Acid, Alcohol

1 Certified organic

Other Information

STORAGE AND HANDLING SECTION

  • Protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

CustomerCare@treeactiv.com | (888) 201-6444 | www.treeactiv.com

SPL UNCLASSIFIED SECTION

Distributed by: Leiluna LLC, Wilmington, DE 19807

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TreeActiv

EARTH GROWN, HAND CRAFTED

SAFFLOWER OLEOSOMES
DAILY NATURAL
MOISTURIZING SUNSCREEN

BROAD SPECTRUM SPF 30

1.7 fl oz (50 ml)

Principal Display Panel - 50 ml Bottle Label
Principal Display Panel - 50 ml Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72841-101-012024-01-30C16284748780-11030e365-5222-111a-e063-dadaa90a10e2TreeActiv Safflower Oleosomes Daily Natural Moisturizing Sunscreen Broad Spectrum SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72841-101-01TreeActiv Safflower Oleosomes Daily Natural Moisturizing Sunscreen Broad Spectrum SPF 3050 mL in 1 BOTTLE, PUMPLOTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72841-101TREEACTIV SAFFLOWER OLEOSOMES DAILY NATURAL MOISTURIZING SUNSCREEN BROAD SPECTRUM SPF 30 (ZINC OXIDE) LOTION [LEILUNA LLC]1Legacy NDC, 1 package rows20190501_42e1cf70-87f6-4d64-a846-6037aebefa91.zip

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
72841-10172841-101-01

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
ZINC OXIDESOI2LOH54ZACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
SAFFLOWER OIL65UEH262ISIACT
POLYSORBATE 60CAL22UVI4MIACT
CETYL ALCOHOL936JST6JCNIACT
GLYCERINPDC6A3C0OXIACT
SUNFLOWER OIL3W1JG795YIIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
COCO GLUCOSIDEICS790225BIACT
ISOSTEARIC ACIDX33R8U0062IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
LEUCONOSTOC/RADISH ROOT FERMENT FILTRATED2QHA03458IACT
BETASIZOFIRAN2X51AD1X3TIACT
WITCH HAZEL101I4J0U34IACT
XANTHAN GUMTTV12P4NEEIACT
CITRIC ACID ACETATEDSO12WL7AUIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CAPRYLYL GLYCOL00YIU5438UIACT
FYTIC ACID7IGF0S7R8IIACT

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
e37500c7-f08c-42e2-8c92-26aaac6430b542e1cf70-87f6-4d64-a846-6037aebefa912019-04-15WarningsExact identifier
spl id: e37500c7-f08c-42e2-8c92-26aaac6430b5
spl set id: 42e1cf70-87f6-4d64-a846-6037aebefa91

Reported adverse events (FAERS/openFDA)#

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