FDA.reportPublic FDA data

Invincible Setting powder SPF 45

Manufacturer
TAYLOR JAMES, LTD. | Kolmar Laboratories, Inc.
Effective date
2017-01-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:48:27

Label at a glance#

ProductInvincible Setting powder SPF 45
Active ingredientTITANIUM DIOXIDE, ZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients                 Purpose

Titanium Dioxide 15.7%        Sunscreen

Zinc Oxide 20%                    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 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 Center right away

DOSAGE & ADMINISTRATION SECTION

Directions ​Apply liberally and evenly to face before sun exposure 

Reapply after 40 minutes of swimming or sweating

immediately after towel drying

at least every 2 hours

Children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients  ​Silica, Calcium Aluminum Borosilicate, Polymethyl Methacrylate, Lauroyl Lysine, Phenoxyethanol,  Water (Aqua), Sodium Dehydroacetate, Ascorbyl palmitate, Ceteareth-25, Glycerin, Cetyl Alcohol, Cholesterol, Ceramide NP, Behenic Acid, Ethylhexyglycerin, Ceramide NS, Ceramide AP, Ceramide EOP, Ceramide EOS, Caprooyl Pytosphingosine, Caprooyl Sphingosine, Tocopherol, Titanium Dioxide (CI77891), Iron Oxides (CI 77491)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Invincible Setting Powder

SPF 45

100% mineral. Sweat Resistant

0.09 oz / 2.5 g

outerouter

jarjar

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75936-105-012020-01-31C16284748780-19d75b9d0-4438-f424-e053-dadaa90a57ceInvincible Setting Powder SPF 45

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75936-105-01Invincible Setting powder SPF 454.5 g in 1 PACKAGEPOWDER4.51

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75936-105INVINCIBLE SETTING POWDER SPF 45 (TITANIUM DIOXIDE, ZINC OXIDE) POWDER [TAYLOR JAMES, LTD.]1Legacy NDC, 1 package rows20170113_717ea2fc-b739-4378-8724-21f6bd835333.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
75936-10575936-105-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPACTIB
ZINC OXIDESOI2LOH54ZACTIM
SILICON DIOXIDEETJ7Z6XBU4IACT
CALCIUM ALUMINUM BOROSILICATE3JRB8A35M0IACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
LAUROYL LYSINE113171Q70BIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
SODIUM DEHYDROACETATE8W46YN971GIACT
ASCORBYL PALMITATEQN83US2B0NIACT
CETEARETH-258FA93U5T67IACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
CHOLESTEROL97C5T2UQ7JIACT
CERAMIDE NP4370DF050BIACT
BEHENIC ACIDH390488X0AIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
CERAMIDE NGC04977SRJ5IACT
Ceramide APF1X8L2B00JIACT
CERAMIDE 15THT33P7X7IACT
N-HEXANOYLSPHINGOSINE038753E78JIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
FERRIC OXIDE RED1K09F3G675IACT

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
344ebfe9-7ead-48ac-8fbc-ec8c2ad6e98c717ea2fc-b739-4378-8724-21f6bd8353332017-01-13WarningsExact identifier
spl id: 344ebfe9-7ead-48ac-8fbc-ec8c2ad6e98c
spl set id: 717ea2fc-b739-4378-8724-21f6bd835333

Reported adverse events (FAERS/openFDA)#

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