FDA.reportPublic FDA data

Zinc Oxide

Manufacturer
Twincraft Inc.
Effective date
2025-12-17
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
monthly-update
Hydrated at
2026-06-03 17:46:09

Label at a glance#

ProductNative Mineral Suncare Zinc Oxide Sunscreen Tropical Breeze Broad Spectrum 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 water resistant sunscreen if 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in sun, especially from 1...

Storage and handling

protect this product from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

ZINC OXIDE 17%

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

OTC - DO NOT USE SECTION

  • on damaged or broken skin

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 liberally 15 minutes before sun exposure
  • reapply at least every 2 hours
  • use water resistant sunscreen if 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 a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
    • limit time in sun, especially from 10 a.m. – 2 p.m.
    • wear long-sleeved 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, caprylic/capric triglyceride, isohexadecane, glycerin, steareth-21, polyhydroxystearic acid, C13-14 isoalkane, steareth-2, laureth-7, stearyl alcohol, behenyl alcohol, cetyl alcohol, polyacrylamide, triethoxycaprylylsilane, benzyl alcohol, fragrance

SPL UNCLASSIFIED SECTION

Distr. by Native San Francisco, CA 94111

Questions or comments?

OTC - QUESTIONS SECTION

Please contact support@nativecos.com

PRINCIPAL DISPLAY PANEL - 207 mL Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

30

MINERAL SUNCARE

ZINC OXIDE SUNSCREEN

NATIVE

TROPICAL BREEZE

BROAD SPECTRUM SPF 30

7 FL OZ (207 mL)

NATNAT

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130030772235669GTIN-13: 0030772235669
EAN-13: 0030772235669
GTIN-12: 030772235669
UPC-A: 030772235669
GTIN storage (14 digits): 00030772235669		NAT.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64412-550864412-5508-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYACRYLAMIDE (1300000 MW)SC5Y4X78TGIACT
STEARETH-2153J3F32P58IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
BEHENYL ALCOHOL9G1OE216XYIACT
CETYL ALCOHOL936JST6JCNIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
CAPRYLIC/CAPRIC TRIGLYCERIDEC9H2L21V7UIACT
BENZYL ALCOHOLLKG8494WBHIACT
ISOHEXADECANE918X1OUF1EIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
STEARETH-2V56DFE46J5IACT
LAURETH-7Z95S6G8201IACT
STEARYL ALCOHOL2KR89I4H1YIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
ZINC OXIDESOI2LOH54ZACTIB

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
462cf67c-7a74-1bdb-e063-6394a90af2c7462cf6bf-d596-1a1e-e063-6394a90a635e2025-12-17WarningsExact identifier
spl id: 462cf67c-7a74-1bdb-e063-6394a90af2c7
spl set id: 462cf6bf-d596-1a1e-e063-6394a90a635e

Reported adverse events (FAERS/openFDA)#

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