FDA.reportPublic FDA data

Sun Goo Mineral Sun stick

Manufacturer
Sun Goo Inc
Effective date
2022-11-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:51:57

Label at a glance#

ProductSun Goo Mineral Sun stick
Active ingredientZINC OXIDE
Label structure8 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 Children under 6 months of age ask a doctor Sun protection measures reapply after 40 minutes of swimming or sweating, immediately after towel drying, at least every two hours, spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other s...

Label contents#

Full prescribing information#

Active Ingredient (s)

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 18%

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 doctor if rash occurs
Keep out of reach of children. If a product is 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
Children under 6 months of age ask a doctor
Sun protection measures reapply after 40 minutes of swimming or sweating, immediately after towel drying, at least every two hours, spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with Broad Spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10:00 a.m. – 2:00 p.m. wear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Olive oil, beeswax, jojoba seed oil, cocoa seed butter, rosemary leaf extract, shea butter

Other information

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun. Do not use if the seal is broken

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82395-001-012024-01-30C16284748780-11030e365-25f2-111a-e063-dadaa90a10e24ac2f15b-0ba7-434d-9e5d-f6d0f2a7e7db

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82395-001-01Sun Goo Mineral Sun stick15 mL in 1 TUBESTICK153
82395-001-01Sun Goo Mineral Sun stick1 in 1 CARTONSTICK13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82395-001SUN GOO MINERAL SUN STICK (ZINC OXIDE) STICK [SUN GOO INC]3Legacy NDC, 2 package rows20221201_4ac2f15b-0ba7-434d-9e5d-f6d0f2a7e7db.zip

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82395-00182395-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
OLIVE OIL6UYK2W1W1EIACT
YELLOW WAX2ZA36H0S2VIACT
JOJOBA OIL724GKU717MIACT
COCOA BUTTER512OYT1CRRIACT
SHEA BUTTERK49155WL9YIACT
ROSEMARYIJ67X351P9IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ZINC OXIDESOI2LOH54ZACTIM

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
eeb4a370-9b58-5565-e053-2a95a90a93f94ac2f15b-0ba7-434d-9e5d-f6d0f2a7e7db2022-11-30WarningsExact identifier
spl id: eeb4a370-9b58-5565-e053-2a95a90a93f9
spl set id: 4ac2f15b-0ba7-434d-9e5d-f6d0f2a7e7db

Reported adverse events (FAERS/openFDA)#

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