FDA.reportPublic FDA data

SETT Mineral Sunscreen SPF 50

Manufacturer
Sett Surf, Ltd.
Effective date
2023-11-06
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:23

Label at a glance#

ProductSETT Mineral Sunscreen SPF 50
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure7 sections

Indications and uses

Helps prevent sunburn If used as directed with othe sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

Dosage and administration

• Shake well before use • Apply liberally to all exposed skin 15 minutes before sun exposure • - after 80 minutes of swimming or sweating • Immediately after towel drying - At least every 2 hours • Sun Protection Measures: Spending time in the sun increaases 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 ...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide (non-nano) 12.5%

Titanium Dioxide (non-nano) 4.5%

Purpose

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

  • Helps prevent sunburn
  • If used as directed with othe sun protection measures (see ), decreases the risk of skin cancer and early skin aging caused by the sun. Directions

WARNINGS

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

Stop use and ask a doctor 

OTC - STOP USE SECTION

if rash occurs.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

• Shake well before use • Apply liberally to all exposed skin 15 minutes before sun exposure • - after 80 minutes of swimming or sweating • Immediately after towel drying - At least every 2 hours • Sun Protection Measures: Spending time in the sun increaases 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 measres including: • Limit time in the sun, especially between 10am and 2pm • Wear long-sleeved shorts, pants, hats and sunglasses • For children under 6 months of age - ask a doctor. Reapply

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

Store below 90ºF / 30ºC

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Aqua, Glycine Max (Soybean) Oil, Hydroxy Ethyl Cellulose (Cellulose Gum), Xanthan Gum, Glycerol Mono Stearate, Barium Sulphate, Cetearyl Alcohol, Glycerin, Cocos Nucifera (Coconut) Oil, Ricinus Communis (Castor) Seed Oil, Hydrogenated Castor Oil, Copernicia Cerifera (Carnauba) Wax, Sodium Benzoate, Potassium Sorbate, Potassium Cetyl Phosphate, Cucumber Potpourri, Citrullus Vulgaris (Kalahari Melon) Oil, Simmondsia Chenensis (Jojoba) Oil, Argania Spinosa (Argan) Oil, Aloe Vera Extract, Ascorbic Acid (Vitamin C), Tocopherol Acetate (Vitamin E).

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

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
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
5dbf91a8-ec29-4ffc-807c-e3bae7fb67b1Product name120201123
85bed648-23ca-4804-98e6-e36aee999cadProduct name120190717
80de93b4-8a94-428d-beb7-d644353ee70bProduct name120180424
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
eb4f7d5b-1286-40dc-b8bf-ad87ff51c688Product name120170522
db8eb201-78c7-4590-8a71-fac0a539bd8cProduct name120170404
141092be-5eb5-452e-9f69-2d350aa70a87Product name120161208
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83478-000-002025-01-30C16284748780-12cef2736-a5d8-d83d-e063-dadaa90ab31fSETT Mineral Sunscreen SPF 50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83478-000-00SETT Mineral Sunscreen SPF 50100 mL in 1 POUCHCREAM1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83478-000SETT MINERAL SUNSCREEN SPF 50 (ZINC OXIDE, TITANIUM DIOXIDE) CREAM [SETT SURF, LTD.]21 package rows20231108_acc1e1eb-1d8d-4877-98ed-3a146ea5ed7a.zip

Products#

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

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83478-00083478-000-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SOYBEAN OIL241ATL177AIACT
HYDROXYMETHYL CELLULOSE273FM27VK1IACT
XANTHAN GUMTTV12P4NEEIACT
BARIUM SULFATE25BB7EKE2EIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERINPDC6A3C0OXIACT
COCONUT OILQ9L0O73W7LIACT
CASTOR OILD5340Y2I9GIACT
HYDROGENATED CASTOR OILZF94AP8MEYIACT
CARNAUBA WAXR12CBM0EIZIACT
SODIUM BENZOATEOJ245FE5EUIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
JOJOBA OIL724GKU717MIACT
ARGAN OIL4V59G5UW9XIACT
ALOE VERA LEAFZY81Z83H0XIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
ZINC OXIDESOI2LOH54ZACTIM
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
0989111d-fee1-5abb-e063-6394a90a94c2acc1e1eb-1d8d-4877-98ed-3a146ea5ed7a2023-11-06WarningsExact identifier
spl id: 0989111d-fee1-5abb-e063-6394a90a94c2
spl set id: acc1e1eb-1d8d-4877-98ed-3a146ea5ed7a

Reported adverse events (FAERS/openFDA)#

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