FDA.reportPublic FDA data

Mineral Sunscreen Stick SPF 50

Manufacturer
TAYLOR JAMES, LTD.
Effective date
2021-10-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:42:42

Label at a glance#

ProductMineral Sunscreen Stick SPF 50 Supergoop
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

​Active Ingredients            Purpose

​Zinc Oxide 17% ............... Sunscreen

OTC - PURPOSE SECTION

​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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

WARNINGS SECTION

​Warnings

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

DOSAGE & ADMINISTRATION SECTION

​Directions

  • Apply liberally to face and body at least 15 minutes prior to sun exposure
  • Reapply after 80 minutes of swimming or sweating
  • Immediately after towel drying
  • At least every 2 hours
  • Chlidren under 6 months: Ask a doctor

​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 take other sun protection measures including:

  • Limit time in the sun, especially from 10a.m.-2p.m.
  • Wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Beeswax, Bisabolol,

Butyrospermum Parkii (Shea) Butter, Cannabis Sativa Seed Oil, Euphorbia Cerifera (Candelilla) Wax, Heptyl Undecylenate, Jojoba Esters, Linum Usitatissimum (Linseed) Seed Oil, Octyldodecyl Oleate, Olea Europaea (Olive) Fruit Extract, Olea Europaea (Olive) Oil, Oryzanol, Persea Gratissima (Avocado) Oil, Salvia Hispanica (Chia) Seed Oil, Simmondsia Chinensis (Jojoba) Seed Oil, Theobroma Cocao (Cocoa) Seed Butter, Tocopherol, Triethyl Citrate, Vanilla Planifolia Fruit Extract

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Supergoop

SPF  50

Water resistant (80 minutes)

100% Mineral Sunscreen Stick

With Avocado Oil

Broad Spectrum SPF 50

FrontFront

BackBack

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
75936-511-012023-01-30C16284748780-1f386c649-dccc-0266-e053-dadaa90a7c1aMineral Sunscreen Stick SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75936-511-01Mineral Sunscreen Stick SPF 50Supergoop18.9 g in 1 TUBESTICK18.92

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75936-511MINERAL SUNSCREEN STICK SPF 50 SUPERGOOP (ZINC OXIDE) STICK [TAYLOR JAMES, LTD.]2Legacy NDC, 1 package rows20211012_5d28bedf-e8c6-4856-b345-55537c73f832.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
75936-51175936-511-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
YELLOW WAX2ZA36H0S2VIACT
LEVOMENOL24WE03BX2TIACT
SHEA BUTTERK49155WL9YIACT
CANNABIS SATIVA SEED OIL69VJ1LPN1SIACT
CANDELILLA WAXWL0328HX19IACT
HEPTYL UNDECYLENATEW77QUB6GXOIACT
JOJOBA OIL, RANDOMIZED7F0EV20QYLIACT
LINSEED OIL84XB4DV00WIACT
OCTYLDODECYL OLEATEMCA43PK7MHIACT
BLACK OLIVE2M6QWV94OCIACT
OLIVE OIL6UYK2W1W1EIACT
GAMMA ORYZANOLSST9XCL51MIACT
AVOCADO OIL6VNO72PFC1IACT
CHIA SEED OILMC2LH51BO7IACT
JOJOBA OIL724GKU717MIACT
COCOA BUTTER512OYT1CRRIACT
TOCOPHEROLR0ZB2556P8IACT
TRIETHYL CITRATE8Z96QXD6UMIACT
VANILLAQ74T35078HIACT
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
ce1ab8b5-88de-f3f2-e053-2995a90a02405d28bedf-e8c6-4856-b345-55537c73f8322021-10-11WarningsExact identifier
spl id: ce1ab8b5-88de-f3f2-e053-2995a90a0240
spl set id: 5d28bedf-e8c6-4856-b345-55537c73f832

Reported adverse events (FAERS/openFDA)#

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