FDA.reportPublic FDA data

Zinc oxide Sunscreen Lotion

Manufacturer
Natural Lifestyle Brands, LLC dba GoPure beauty
Effective date
2025-10-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:42:41

Label at a glance#

ProductgoPure Sunscreen
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 generously and evenly 15 minutes before sun exposure • reapply at least every 2 hours • use a 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...

Storage and handling

• protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc oxide 25%

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• apply generously and evenly 15 minutes before sun exposure
• reapply at least every 2 hours
• use a 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 the sun, especially from 10 a.m. – 2 p.m
  • wear long-sleeved shirts, pants, hats, and sunglasses
• children under 6 months of age: Ask a doctor
• apply to face and neck as the last step in your skincare routine

Other information

STORAGE AND HANDLING SECTION

• protect the product in this container from excessive heat and direct sun

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water/Aqua/Eau, Caprylic/Capric Triglyceride, Glycerin, Propanediol, Butyloctyl Salicylate, C13-15 Alkane, Polyhydroxystearic Acid, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, C9-12 Alkane, Isostearic Acid, Isoamyl Laurate, Lecithin, Polyglyceryl-3 Polyricinoleate, Quaternium-90 Bentonite, Coco-Caprylate/Caprate, Caprylhydroxamic Acid, Cocos Nucifera (Coconut) Fruit Extract, Vanilla Planifolia Fruit Extract, Sodium Chloride, Ethyl Vanillin, 1,2-Hexanediol, Galactoarabinan, Triethyl Citrate, Tocopheryl Acetate, Iron Oxides (CI 77491, CI 77492, CI 77499)

Questions or comments?

OTC - QUESTIONS SECTION

+1-800-925-4232

You may also report serious side effects to this phone number. Monday - Friday 9:00 AM - 4:00 PM PST

SPL UNCLASSIFIED SECTION

SAFE & CLEAN

Glow Pure Tinted Mineral SPF

Broad Spectrum SPF 40

CRUELTY-FREE

GLUTEN-FREE

DERMATOLOGIST RECOMMENDED

VEGAN

It's glow time

@gopurebeauty

We created goPure because we believe that everyone deserves to feel confident in their skin -Erin Keyan (goPure co-founder)

LET'S GLOW!

Manufactured for
goPure Beauty
3835 E.
Thousand Oaks
Suite R384
Westlake Village,
CA 91362

GOOD FACE PROJECT APPROVED

ANIMAL TEST-FREE
PeTA

www.gopurebeauty.com

FSC® C158805

FPO

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

goPure SunscreengoPure Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83448-025-15goPure Sunscreen1 in 1 CARTONLOTION14
83448-025-15goPure Sunscreen15 mL in 1 TUBELOTION154
83448-025-50goPure Sunscreen1 in 1 CARTONLOTION14
83448-025-50goPure Sunscreen50 mL in 1 TUBELOTION504

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83448-02583448-025-50, 83448-025-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
C13-15 ALKANE114P5I43UJIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
POLYGLYCERYL-4 DIISOSTEARATE/POLYHYDROXYSTEARATE/SEBACATE687U3PEB2YIACT
C9-12 ALKANE7J5R5W72QMIACT
ISOSTEARIC ACIDX33R8U0062IACT
ISOAMYL LAURATEM1SLX00M3MIACT
LECITHIN, SUNFLOWER834K0WOS5GIACT
POLYGLYCERYL-3 PENTARICINOLEATE7Q0OK5DOT4IACT
QUATERNIUM-90 BENTONITE97K5YEF88CIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
COCONUT3RT3536DHYIACT
VANILLA BEANQ74T35078HIACT
SODIUM CHLORIDE451W47IQ8XIACT
ETHYL VANILLINYC9ST449YJIACT
1,2-HEXANEDIOLTR046Y3K1GIACT
GALACTOARABINANSL4SX1O487IACT
TRIETHYL CITRATE8Z96QXD6UMIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
FERRIC OXIDE RED1K09F3G675IACT
FERROSOFERRIC OXIDEXM0M87F357IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32024-12-13full-release2026-06-01 00:48:43

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
goPure SunscreenZINC OXIDENatural Lifestyle Brands, LLC dba GoPure beautya74ec20b-8436-4030-820c-01fd88134f402025-10-27WarningsExact identifier
ndc (package): 83448-025-50
ndc (package): 83448-025-15
ndc (product): 83448-025
ndc11 (package): 83448002515
ndc11 (package): 83448002550
spl id: 937c741d-6498-4df3-a385-c4866eb3e8b4
spl set id: a74ec20b-8436-4030-820c-01fd88134f40

Reported adverse events (FAERS/openFDA)#

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