FDA.reportPublic FDA data

Prevage Anti-aging eye cream SPF 15

Manufacturer
Revlon | Englewood Lab. INC
Effective date
2025-12-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:29:24

Label at a glance#

ProductPrevage Anti-aging eye cream SPF 15
Active ingredientOXYBENZONE, OCTINOXATE
Label structure10 sections

Indications and uses

Helps proevent sunburn

Dosage and administration

-Apply liberally 15 minutes before sun exposure -Repply: at least every 2 hours Children under 6 months: Ask a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 4.1 %

Oxybenzone 1.4 %

OTC - WHEN USING SECTION

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

Uses

OTC - PURPOSE SECTION

Helps proevent sunburn

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.

WARNINGS AND PRECAUTIONS SECTION

- Skin Cancer/Skin Aging Alert: Spending time in the sun inceases your risk of ksin cancer and easly skin aging. his product has been shown only to proevent subbrun, not skin cancer or early skin aging.

- For external use only

- Do not use on danaged or broken skin

- Stop using and ask a doctor if rash occurs

Directions for Sunscreen Use:

DOSAGE & ADMINISTRATION SECTION

-Apply liberally 15 minutes before sun exposure

-Repply: at least every 2 hours

Children under 6 months: Ask a doctor

INACTIVE INGREDIENT SECTION

WATER/AQUA/EAU, BUTYROSPERMUM PARKII (SHEA) BUTTER, PHYTOSTERYL MACADAMIATE, BUTYLENE GLYCOL, GLYCERIN, DIMETHICONE, SYNTHETIC BEESWAX, CETEARYL ALCOHOL, THEOBROMA CACAO (COCOA) SEED BUTTER, C12-15 ALKYL BENZOATE, STEARYL DIMETHICONE, DIPENTAERYTHRITYL HEXACAPRYLATE/HEXACAPRATE, TRIDECYL TRIMELLITATE, COPERNICIA CERIFERA (CARNAUBA) WAX/CERA CARNAUBA/CIRE DE CARNAUBA, PEG-100 STEARATE, ACETYL TETRAPEPTIDE-5, BEESWAX/CERA ALBA/CIRE D'ABEILLE, BIS-PEG-12 DIMETHICONE, CAPRYLIC/CAPRIC TRIGLYCERIDE, CAPRYLYL GLYCOL, CAPRYLYL METHICONE, CARBOMER, CETEARYL GLUCOSIDE, DIMETHICONE CROSSPOLYMER, DISODIUM EDTA, ETHYLHEXYLGLYCERIN, GLYCEROPHOSPHOINOSITOL LYSINE, GLYCERYL STEARATE, HEXYLENE GLYCOL, HYDROGENATED LECITHIN, HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATE, LECITHIN, MICA, NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE, PEG-20, POLYPHOSPHORYLCHOLINE GLYCOL ACRYLATE, POLYQUATERNIUM-51, PROPYLENE GLYCOL, PVP, RABDOSIA RUBESCENS EXTRACT, SIGESBECKIA ORIENTALIS EXTRACT, SILICA, SODIUM ACRYLATES COPOLYMER, SODIUM CITRATE, SODIUM HYALURONATE, SODIUM HYDROXIDE, SODIUM PCA, SORBITAN TRISTEARATE, STEARETH-100, TREHALOSE, TRIDECYL STEARATE, UREA, VP/EICOSENE COPOLYMER, XANTHAN GUM, BHT, BENZOIC ACID, CETRIMONIUM CHLORIDE, CHLORPHENESIN, DIAZOLIDINYL UREA, METHYLPARABEN, PHENOXYETHANOL, PROPYLPARABEN, SORBIC ACID, TRIACETIN, IRON OXIDES (CI 77492), RED 40 (CI 16035), TITANIUM DIOXIDE (CI 77891).

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 againg caused by the sun

WARNINGS SECTION

  • 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.
  • Stop using and ask a doctor if rash occurs.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Prevage eyePrevage eye

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10967-685-612025-12-29C16284748780-1d6a99b39-e58f-a426-e053-dadaa90af4c2Prevage Anti-aging eye cream SPF 15
10967-685-612023-07-28C16284748780-1d6a99b39-e58f-a426-e053-dadaa90af4c2Prevage Anti-aging eye cream SPF 15
10967-685-612022-02-09C16284748780-1d6a99b39-e58f-a426-e053-dadaa90af4c2Prevage Anti-aging eye cream SPF 15
10967-685-612022-01-28C16284748780-1d6a99b39-e58f-a426-e053-dadaa90af4c2Prevage Anti-aging eye cream SPF 15

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10967-685-61Prevage Anti-aging eye cream SPF 1515 g in 1 JARCREAM153

Products#

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

DailyMed product names page 1 of 2 · 65 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10967-68510967-685-61

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 63 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
SODIUM PYRROLIDONE CARBOXYLATE469OTG57A2IACT
STEARETH-1004OH5W9UM87IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
PEG-100 STEARATEYD01N1999RIACT
GLYCEROPHOSPHOINOSITOL LYSINEX34K43QI7AIACT
SORBITAN TRISTEARATE6LUM696811IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CARNAUBA WAXR12CBM0EIZIACT
CAPRYLYL TRISILOXANEQ95M2P1KJLIACT
HYDROXYDECYL UBIQUINOYL DIPALMITOYL GLYCERATEOV1BT2N8RCIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
COCOA BUTTER512OYT1CRRIACT
STEARYL DIMETHICONE (400 MPA.S AT 50C)R327X197HYIACT
MICAV8A1AW0880IACT
TRIDECYL STEARATEA8OE252M6LIACT
OXYBENZONE95OOS7VE0YACTIB
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SIGESBECKIA ORIENTALIS WHOLEZM9Q0FEI4ZIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
SYNTHETIC BEESWAX08MNR5YE2RIACT
FD&C RED NO. 40WZB9127XOAIACT
ISODON RUBESCENS WHOLE2J2179ITFUIACT
OCTINOXATE4Y5P7MUD51ACTIB
DIMETHICONE 1000MCU2324216IACT
CAPRYLYL GLYCOL00YIU5438UIACT
TRIDECYL TRIMELLITATEFY36J270ESIACT
SORBIC ACIDX045WJ989BIACT
POLYQUATERNIUM-51 (2-METHACRYLOYLOXYETHYL PHOSPHORYLCHOLINE/N-BUTYL METHACRYLATE; 3:7)EL9825H96JIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATEVLW429K27KIACT
POLYETHYLENE GLYCOL 1000U076Q6Q621IACT
TREHALOSEB8WCK70T7IIACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
UREA8W8T17847WIACT
XANTHAN GUMTTV12P4NEEIACT

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
Prevage Anti-aging eye cream SPF 15OCTINOXATE, OXYBENZONERevlonb2a92d72-e634-7379-e053-2995a90a2bca2025-12-29WarningsExact identifier
ndc (package): 10967-685-61
ndc (product): 10967-685
ndc11 (package): 10967068561
spl id: 471d95a4-b49c-ffa1-e063-6294a90a6f12
spl set id: b2a92d72-e634-7379-e053-2995a90a2bca

Reported adverse events (FAERS/openFDA)#

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