FDA.reportPublic FDA data

ClearChoice Sport Shield

Manufacturer
Dermastart Inc.
Effective date
2023-10-23
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:57:54

Label at a glance#

ProductClearChoice Sport Shield
Active ingredientZINC OXIDE
Label structure12 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 liberally 15 minutes before sun exposure reapply    after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours Sun Protection Measures.  Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease the risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in ...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 12%

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

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 a doctor if

OTC - STOP USE SECTION

  • rash occurs

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

  • apply liberally 15 minutes before sun exposure
  • reapply
  •    after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • Sun Protection Measures.  Spending time in the sun increases your risk of skin cancer and early skin aging.  To decrease the 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 10a.m.-2p.m.
  • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months of age: Ask a doctor

Other Information

OTHER SAFETY INFORMATION

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Organic Aloe Vera, Thioctic Acid, Magnesium Ascorbyl Phosphate, Panthenol, Dexpanthenol, Tocopheryl Acetate, Ergocalciferol, Grape Seed Extract, Evening Primrose Oil, Sunflower Seed Oil, Safflower Seed Oil, Slippery Elm Extract, Borage Seed Oil, Alpha Bisabolol, Plantain, Allantoin, Hyaluronic Acid, Olive Squalane.

ClearChoice Sunscreen Tube Label (83722-000-00)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ClearChoice Sunscreen Tube LabelClearChoice Sunscreen Tube Label

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
a1367f07-14a3-4895-a6e7-61ee9285308bProduct name120190415
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
83722-000-002025-12-01C16284748780-13b156c62-2cca-fb37-e063-e6dba90a4e07ClearChoice Sport Shield
83722-000-002025-07-29C16284748780-13b156c62-2cca-fb37-e063-e6dba90a4e07ClearChoice Sport Shield

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83722-000-00ClearChoice Sport Shield120 mL in 1 TUBELOTION1203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83722-000CLEARCHOICE SPORT SHIELD (ZINC OXIDE) LOTION [DERMASTART INC.]31 package rows20231026_d8d24ed4-7676-43ea-8c94-e2e2be678cff.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83722-00083722-000-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA WHOLEKIZ4X2EHYXIACT
ALPHA LIPOIC ACID73Y7P0K73YIACT
MAGNESIUM ASCORBYL PHOSPHATE0R822556M5IACT
PANTHENOLWV9CM0O67ZIACT
DEXPANTHENOL1O6C93RI7ZIACT
.ALPHA.-TOCOPHEROL ACETATE, DL-WR1WPI7EW8IACT
ERGOCALCIFEROLVS041H42XCIACT
VITIS VINIFERA SEEDC34U15ICXAIACT
EVENING PRIMROSE OIL3Q9L08K71NIACT
SUNFLOWER OIL3W1JG795YIIACT
SAFFLOWER SEED OIL POLYGLYCERYL-6 ESTERSR2Z4507WJNIACT
BORAGE SEED OILF8XAG1755SIACT
.ALPHA.-BISABOLOL, (+/-)-36HQN158VCIACT
MUSA X PARADISIACA LEAF2UIJ27N6EDIACT
ALLANTOIN344S277G0ZIACT
HYALURONIC ACIDS270N0TRQYIACT
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
086196b3-2126-70bb-e063-6394a90aa0b8d8d24ed4-7676-43ea-8c94-e2e2be678cff2023-10-23WarningsExact identifier
spl id: 086196b3-2126-70bb-e063-6394a90aa0b8
spl set id: d8d24ed4-7676-43ea-8c94-e2e2be678cff

Reported adverse events (FAERS/openFDA)#

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