Sqween 100% Mineral Sunscreen Broad Spectrum SPF 30 Water Resistant

Manufacturer
SQWEEN LLC
Effective date
2024-06-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:14:06

Label at a glance#

ProductSqween 100% Mineral Sunscreen Broad Spectrum SPF 30 Water Resistant
Active ingredientZINC OXIDE
Label structure8 sections

Indications and uses

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

Dosage and administration

Apply liberally to exposed areas 15 minutes before sun exposure. Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel drying.  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other protection measures including Sun Protection Measures Limit ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 15%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

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

Warning

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 doctor

OTC - STOP USE SECTION

if rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If a product is swallowed get medical help or contact a Poison Control right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally to exposed areas 15 minutes before sun exposure.

Reapply at least every two hours, after 80 minutes of swimming or sweating, or immediately after towel drying.

  •  Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other protection measures including Sun Protection Measures
  • Limit time in the sun, especially from 10 a.m. - 2 p.m.
  • Wear long-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: ask a doctor.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Water, C15-19 Alkane, Isocetyl Stearoyl Stearate, Undecane, Tribehenin, Silica, Tocopheryl Acetate, Helianthus Annuus (Sunflower) Seed Oil, Capryloyl Glycerin/Sebacic Acid Copolymer, Glyceryl Stearate, Simmondsia Chinensis (Jojoba) Seed Oil, Tridecane, Leuconostoc/Radish Root Ferment Filtrate, Lactobacillus, Aloe Barbadensis Leaf, Hyaluronic Acid, Acacia Senegal Gum, Xanthan Gum, Cocos Nucifera (Coconut) Fruit Extract May Contain: Indigofera Tinctoria Leaf Extract, Caesalpinia Sappan Bark Extract, Synthetic Fluorphlogopite, Titanium Dioxide, Tin Oxide









Other Information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Contact for Questions: (877) 849-1983

Distributed by SQWEEN, LLC: New York, NY 10065

MADE IN THE USA with US & imported materials

Sqween 100% Mineral Sunscreen Broad Spectrum SPF 30 Water Resistant

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
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83005-0001-1Sqween 100% Mineral Sunscreen Broad Spectrum SPF 30 Water Resistant60 mL in 1 TUBELOTION604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83005-0001SQWEEN 100% MINERAL SUNSCREEN BROAD SPECTRUM SPF 30 WATER RESISTANT (ZINC OXIDE) LOTION [SQWEEN LLC]4Current NDC, Legacy NDC, 1 package rows20240625_b5bf1c4c-7c48-423c-b4fc-52ae57f339fd.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83005-000183005-0001-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

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
Sqween 100% Mineral Sunscreen Broad Spectrum SPF 30 Water ResistantZINC OXIDESQWEEN LLCb5bf1c4c-7c48-423c-b4fc-52ae57f339fd2024-06-24WarningsExact identifier
ndc (package): 83005-0001-1
ndc (product): 83005-0001
ndc11 (package): 83005000101
spl id: 1ba4b6fc-7878-d25e-e063-6394a90a8d60
spl set id: b5bf1c4c-7c48-423c-b4fc-52ae57f339fd

Reported adverse events (FAERS/openFDA)#

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