FDA.reportPublic FDA data

Native Mineral Sunscreen Broad Spectrum SPF 30 Tropical Breeze - Twincraft

Manufacturer
Twincraft Inc.
Effective date
2024-10-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:51:04

Label at a glance#

ProductNative Mineral Sunscreen Broad Spectrum SPF 30 Tropical Breeze - Twincraft
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 20%

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, coconut alkanes, glycerin, cetearyl alcohol, coco-glucoside, arachidyl alcohol, behenyl alcohol, arachidyl glucoside, polyhydroxystearic acid, benzyl alcohol, xanthan gum, coco-caprylate/caprate, fragrance, tocopherol, helianthus annuus (sunflower) seed oil

SPL UNCLASSIFIED SECTION

Distr. by Native San Francisco, CA 94111

Questions or comments?

OTC - QUESTIONS SECTION

Please contact support@nativecos.com

PRINCIPAL DISPLAY PANEL - 147 mL Tube

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BROAD SPECTRUM SPF 30

MINERAL SUNCARE

ZINC OXIDE SUNSCREEN

NATIVE

TROPICAL BREEZE

NO OXYBENZONE

NO OCTINOXATE

5 FL OZ (147 mL)

Native SPF 30 Tropical Breeze ArtworkNative SPF 30 Tropical Breeze Artwork

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
64412-500164412-5001-1

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
COCONUT ALKANES1E5KJY107TIACT
COCO GLUCOSIDEICS790225BIACT
COCO-CAPRYLATE/CAPRATE8D9H4QU99HIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
TOCOPHEROLR0ZB2556P8IACT
DOCOSANOL9G1OE216XYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
SUNFLOWER OIL3W1JG795YIIACT
BENZYL ALCOHOLLKG8494WBHIACT
XANTHAN GUMTTV12P4NEEIACT
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
23a91a9b-20e5-a0f1-e063-6394a90acd4023a91a8f-2c4b-c558-e063-6394a90a7e7d2024-10-04WarningsExact identifier
spl id: 23a91a9b-20e5-a0f1-e063-6394a90acd40
spl set id: 23a91a8f-2c4b-c558-e063-6394a90a7e7d

Reported adverse events (FAERS/openFDA)#

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