FDA.reportPublic FDA data

Fair Foundation SPF 15

Manufacturer
Orveon Global US, LLC
Effective date
2023-10-04
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:04:20

Label at a glance#

ProductFair Foundation SPF 15
Active ingredientZINC OXIDE, TITANIUM DIOXIDE
Label structure10 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 Use a water-resistant sunscreen if swimming or sweating Reapply at least every 2 hours Sun protection measures. Spending time in the sun increases your risk of skin cancer or early skin aging. To decrease this risk, regularly use a a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including: Limit time in the sun, especially from ...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 25%

Zinc Oxide 19%

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

  • Skin cancer/skin aging alert: spending time in the sun increases your risk of cancer and early aging
  • This product has been shown only to help prevent sunburn, not skin cancer or early aging
  • For External use only
  • Do not use on damage or broken skin
  • When using this product keep out of eyes. Rinse with water to remove
  • Stop use and ask doctor if rash occurs

Inactive ingredients

INACTIVE INGREDIENT SECTION

Bismuth Oxychloride, Iron Oxides, Mica, Titanium Dioxide, Zinc Oxide

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-795-4747

Directions

INSTRUCTIONS FOR USE SECTION

Apply liberally 15 minutes before sun exposure
Use a water-resistant sunscreen if swimming or sweating
Reapply at least every 2 hours
Sun protection measures. Spending time in the sun increases your risk of skin cancer or early skin aging. To decrease this risk, regularly use a a sunscreen with a broad spectrum SPF of 15 or higher and other sun protection measures including:
Limit time in the sun, especially from 10 a.m. - 2 p.m.
Wear long sleeve shirts, pants, hats, and sunglasses
Children under 6 month: ask a doctor

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If product is swallowed get medical help or contact a poison control center right away.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabel continuedLabel continued

Fair 01Fair 01

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
98132-871-182022-12-23C16284748780-19855d018-e2b5-cd31-e053-dbdaa90ab51aBareMineral Original SPF 15 Foundation Fair
98132-879-082022-12-23C16284748780-19855d018-e2b5-cd31-e053-dbdaa90ab51aBareMineral Original SPF 15 Foundation Fair
98132-871-182022-01-28C16284748780-19855d018-e2b5-cd31-e053-dbdaa90ab51aBareMineral Original SPF 15 Foundation Fair
98132-879-082022-01-28C16284748780-19855d018-e2b5-cd31-e053-dbdaa90ab51aBareMineral Original SPF 15 Foundation Fair
98132-871-182021-07-23C16284748780-19855d018-e2b5-cd31-e053-dbdaa90ab51aBareMineral Original SPF 15 Foundation Fair
98132-879-082021-07-23C16284748780-19855d018-e2b5-cd31-e053-dbdaa90ab51aBareMineral Original SPF 15 Foundation Fair
98132-871-182020-07-22C16284748780-19855d018-e2b5-cd31-e053-dbdaa90ab51aBareMineral Original SPF 15 Foundation Fair
98132-879-082020-07-22C16284748780-19855d018-e2b5-cd31-e053-dbdaa90ab51aBareMineral Original SPF 15 Foundation Fair
98132-871-182019-11-27C16284748780-19855d018-e2b5-cd31-e053-dbdaa90ab51aBareMineral Original SPF 15 Foundation Fair

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
98132-871-18Fair Foundation SPF 1536 in 1 CASEPOWDER364
98132-871-18Fair Foundation SPF 1518 g in 1 JARPOWDER184

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
98132-871FAIR FOUNDATION SPF 15 (ZINC OXIDE, TITANIUM DIOXIDE) POWDER [ORVEON GLOBAL US, LLC]4Current NDC, Legacy NDC, 2 package rows20231215_491a5768-1aad-458e-b4d6-72ea085d1d9f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Titanium DioxideACTIVE INGREDIENT15FIX9V2JP2
Zinc OxideACTIVE INGREDIENTSOI2LOH54Z2
Titanium DioxideACTIVE MOIETY15FIX9V2JP2
Zinc OxideACTIVE MOIETYSOI2LOH54Z2
BISMUTH OXYCHLORIDEINACTIVE INGREDIENT4ZR792I5872
BROWN IRON OXIDEINACTIVE INGREDIENT1N032N7MFO2
FERRIC OXIDE YELLOWINACTIVE INGREDIENTEX438O2MRT2
MICAINACTIVE INGREDIENTV8A1AW08802

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
98132-87198132-871-18

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
MICAV8A1AW0880IACT
BISMUTH OXYCHLORIDE4ZR792I587IACT
BROWN IRON OXIDE1N032N7MFOIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
ZINC OXIDESOI2LOH54ZACTIB
TITANIUM DIOXIDE15FIX9V2JPACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 8 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
BROWN IRON OXIDEBROWN IRON OXIDE1N032N7MFOTABLET, FILM COATED / ORAL0.2 mgExact identifier — unii candidate
6 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTPOWDER / RESPIRATORY (INHALATION)0.04 mgExact identifier — unii+dosage form
2 equally ranked IID candidates
BROWN IRON OXIDEBROWN IRON OXIDE1N032N7MFOCAPSULE / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates
BROWN IRON OXIDEBROWN IRON OXIDE1N032N7MFOTABLET / ORAL0.79 mgExact identifier — unii candidate
6 equally ranked IID candidates
FERRIC OXIDE YELLOWFERRIC OXIDE YELLOWEX438O2MRTPOWDER / RESPIRATORY (INHALATION)0.04 mgExact identifier — unii+dosage form
2 equally ranked IID candidates
BROWN IRON OXIDEBROWN IRON OXIDE1N032N7MFOTABLET / ORAL0.79 mgExact identifier — unii candidate
6 equally ranked IID candidates
BROWN IRON OXIDEBROWN IRON OXIDE1N032N7MFOTABLET, FILM COATED / ORAL0.2 mgExact identifier — unii candidate
6 equally ranked IID candidates
BROWN IRON OXIDEBROWN IRON OXIDE1N032N7MFOCAPSULE / ORALNAExact identifier — unii candidate
6 equally ranked IID candidates

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
Fair Foundation SPF 15ZINC OXIDE, TITANIUM DIOXIDEOrveon Global US, LLC491a5768-1aad-458e-b4d6-72ea085d1d9f2023-10-04WarningsExact identifier
ndc (package): 98132-871-18
ndc (product): 98132-871
ndc11 (package): 98132087118
spl id: 06e6ebb0-493c-a18f-e063-6394a90acaa1
spl set id: 491a5768-1aad-458e-b4d6-72ea085d1d9f

Reported adverse events (FAERS/openFDA)#

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