FDA.reportPublic FDA data

Revlon New Complexion One-Step Perfect Make-Up

Manufacturer
Revlon Consumer Products Corp | REVLON, INC.
Effective date
2024-01-12
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:14:33

Label at a glance#

ProductRevlon New Complexion One-Step Perfect Make-Up
Active ingredientTITANIUM DIOXIDE
Label structure9 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

Label contents#

Full prescribing information#

Active Ingredients:

OTC - ACTIVE INGREDIENT SECTION

Titanium Dioxide 4%

Purpose:

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 notuse on damaged or broken skin
  • When using this product: Keep out of eyes.  Rinse with water to remove.
  • Stop use and ask a doctor if a rash occurs
  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control center right away

Directions:

  • Apply liberally 15 minutes before sun exposure
  • Use a water resistant sunscreen if swimming or sweating
  • Reapply at least every 2 hours
  • Children under 6 months: Ask a doctor.

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 SPF value of 15 or higher and other sun protection measures including:

  • Limit time in the sun, especially from 10 am - 2 pm
  • Wear long-sleeved shirts, pants, hats and sunglasses.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

DIMETHICONE,ISOPROPYL,ISOSTEARATE,TALC,SILICA,NEOPENTYL,GLYCOL,DIETHYLHEXANOATE,TRIBEHENIN,ISOSTEARYL,BEHENATE,NYLON-12,BORON,NITRIDE,LAUROYL,LYSINE,TRIDECYL,TRIMELLITATE,MYRISTYL,MYRISTATE,CANDELILLA,CERA,((EUPHORBIA,CERIFERA,(CANDELILLA)WAX),CIRE,DE,CANDELILLA,POLYGLYCERYL-4,ISOSTEARATE,SORBITAN,TRIOLEATE,PENTAHYDROSQUALENE,LAURYL,PEG/PPG-18/18,METHICONE,SACCHAROMYCES,ZINC,FERMENT,SACCHAROMYCES,COPPER,FERMENT,SACCHAROMYCES,MANGANESE,FERMENT,SACCHAROMYCES,IRON,FERMENT,SACCHAROMYCES,SILICON,FERMENT,SACCHAROMYCES,POTASSIUM,FERMENT,CYCLOMETHICONE,SOY,AMINO,ACIDS,CERA,CARNAUBA,((COPERNICIA,CERIFERA,(CARNAUBA),WAX),CIRE,DE,CARNAUBA,TRIMETHYLSILOXYSILICATE,POLYETHYLENE,ETHYLENE/METHACRYLATE,COPOLYMER,LECITHIN,ISOPROPYL,TITANIUM,TRIISOSTEARATE,ALUMINA,BARIUM,SULFATE,DEHYDROACETIC,ACID,METHYLPARABEN,ETHYLPARABEN,PROPYLPARABEN,PHENOXYETHANOL,BHT

May Contain: Mica, Titanium Dioxide (Ci 77891), Iron Oxides (CI 77491, 77492, 77499)

DOSAGE & ADMINISTRATION SECTION

As needed

INDICATIONS & USAGE SECTION

Helps prevent sunburn

OTC - PURPOSE SECTION

Sunscreen

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed seek medical help or contact a Poison Control Center right away.

Principal Display Panel:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

​REVLON

New Complexion SPF 15 Makeup

SPF 15

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10967-606-352024-01-12C16284748780-1ba0f9c33-5312-a910-e053-dadaa90a0b85Revlon New Complexion One-Step Perfect Make-Up
10967-606-352021-01-29C16284748780-1ba0f9c33-5312-a910-e053-dadaa90a0b85Revlon New Complexion One-Step Perfect Make-Up

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10967-606REVLON NEW COMPLEXION ONE-STEP PERFECT MAKE-UP (TITANIUM DIOXIDE MAKE-UP) PASTE [REVLON CONSUMER PRODUCTS CORP]3Legacy NDC20240113_41488f1a-cf6f-124b-e054-00144ff88e88.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10967-60610967-606-35

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIMETHICONE92RU3N3Y1OIACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHYLPARABENA2I8C7HI9TIACT
ETHYLPARABEN14255EXE39IACT
TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8)5041RX63GNIACT
TRIBEHENIN8OC9U7TQZ0IACT
NYLON-12446U8J075BIACT
ALUMINUM OXIDELMI26O6933IACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CYCLOMETHICONE 6XHK3U310BAIACT
ISOPROPYL ISOSTEARATEC67IXB9Y7TIACT
TALC7SEV7J4R1UIACT
NEOPENTYL GLYCOL DIETHYLHEXANOATEU68ZV6W62CIACT
ISOSTEARYL BEHENATENA95U012OWIACT
BORON NITRIDE2U4T60A6YDIACT
LAUROYL LYSINE113171Q70BIACT
TRIDECYL TRIMELLITATEFY36J270ESIACT
MYRISTYL MYRISTATE4042ZC00DYIACT
CANDELILLA WAXWL0328HX19IACT
POLYGLYCERYL-4 ISOSTEARATE820DPX33S7IACT
SORBITAN TRIOLEATEQE6F49RPJ1IACT
2,10,15,19,23-PENTAHYDROSQUALENE6IWZ426YD6IACT
LAURYL PEG/PPG-18/18 METHICONEZJ5S27D9NXIACT
AMINO ACIDS, SOYNWB9514AZMIACT
CARNAUBA WAXR12CBM0EIZIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
ISOPROPYL TITANIUM TRIISOSTEARATE949E3KBJ1IIACT
BARIUM SULFATE25BB7EKE2EIACT
DEHYDROACETIC ACID2KAG279R6RIACT
PROPYLPARABENZ8IX2SC1OHIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
TITANIUM DIOXIDE15FIX9V2JPACTIB

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
471ce3f9-ef2e-f3d4-e063-6294a90a1d1241488f1a-cf6f-124b-e054-00144ff88e882025-12-29WarningsExact identifier
spl set id: 41488f1a-cf6f-124b-e054-00144ff88e88

Reported adverse events (FAERS/openFDA)#

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