FDA.reportPublic FDA data

Invincible Setting Powder SPF 45 medium

Manufacturer
TAYLOR JAMES, LTD. | Kolmar Laboratories, Inc.
Effective date
2018-01-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:10

Label at a glance#

ProductInvincible Setting Powder SPF 45 medium
Active ingredientZINC OXIDE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients      Purpose

Zinc Oxide 24.5%      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.  If product is swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE SECTION

Stop use and ask a doctor if rash occurs

WARNINGS SECTION

Warnings

For external use only

Do not use on damaged or broken skin

When using this product keep out of eyes. Rinse with water to remove.

DOSAGE & ADMINISTRATION SECTION

Directions

  • apply generously and evenly 15 minutes before sun exposure
  • reapply 
  • after 40 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 this risk, regularly use a sunscreen with a Broad Spectrum value of 15 or higher and other sun protections 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: Ask a doctor

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Calcium Aluminum Borosilicate, Silica, Polymethyl Methacrylate, Ethylhexylglycerin, Triethoxycaprylysilane, Nylon-6/12, Sodium Dehydroacetate, Olive Glycerides, Ascorbyl Palmitate, Ceramide 3. May contain +/- Iron Oxides (CI 77492, CI 77491, CI 77499), Titanium Dioxide (CI 77891)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Invincible Setting Powder SPF 45

100% Mineral + Sweat resistant 

Medium

0.15 oz./ 4.25 g

SecondarySecondary

WrapWrap

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
75936-147-022022-01-28C16284748780-1d6a99b39-68f5-a426-e053-dadaa90af4c2Invincible Setting Powder SPF 45 Medium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
75936-147-01Invincible Setting Powder SPF 45 medium4.25 g in 1 PACKAGEPOWDER4.251
75936-147-02Invincible Setting Powder SPF 45 medium1 in 1 BOXPOWDER11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
75936-147INVINCIBLE SETTING POWDER SPF 45 MEDIUM (ZINC OXIDE) POWDER [TAYLOR JAMES, LTD.]1Legacy NDC, 2 package rows20180116_ba603759-d164-41ff-9191-2675fe0182e6.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
75936-14775936-147-01, 75936-147-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
CALCIUM ALUMINUM BOROSILICATE3JRB8A35M0IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POLY(METHYL METHACRYLATE; 450000 MW)Z47NNT4J11IACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
SODIUM DEHYDROACETATE8W46YN971GIACT
ASCORBYL PALMITATEQN83US2B0NIACT
CERAMIDE 34370DF050BIACT
FERRIC OXIDE RED1K09F3G675CNTM
FERRIC OXIDE YELLOWEX438O2MRTCNTM
FERROSOFERRIC OXIDEXM0M87F357CNTM
TITANIUM DIOXIDE15FIX9V2JPCNTM

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
d791fe57-f850-4032-8e2d-0b5178eb7f52ba603759-d164-41ff-9191-2675fe0182e62018-01-15WarningsExact identifier
spl id: d791fe57-f850-4032-8e2d-0b5178eb7f52
spl set id: ba603759-d164-41ff-9191-2675fe0182e6

Reported adverse events (FAERS/openFDA)#

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