FDA.reportPublic FDA data

ROC MULTI CORREXION 5 IN 1 DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF30

Manufacturer
ROC Skincare | Janssen Cilag
Effective date
2019-12-04
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:01:48

Label at a glance#

ProductROC MULTI CORREXION 5 IN 1 DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF30
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL PRINCIPAL DISPLAY PANELROC MULTI CORREXION 5 IN 1 DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF30.jpgROC MULTI CORREXION 5 IN 1 DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF30.jpg

OTC - PURPOSE

OTC - PURPOSE SECTION

Active ingredientsPurposeAvobenzone (2%)SunscreenHomosalate (4%)SunscreenOctisalate (4%)SunscreenOctocrylene (2%)SunscreenROC MULTI CORREXION 5 IN 1 DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF30.jpgROC MULTI CORREXION 5 IN 1 DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF30.jpg

OTC - KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

USES

INDICATIONS & USAGE SECTION

Helps prevent sunburnif 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 not use 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 rash occurs

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:apply generously and evenly15 minutes before sun exposurereapply at least every 2 hoursuse a water resistant sunscreen if swimming or sweatingSun 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 a.m. – 2 p.m.wear long-sleeved shirts, pants, hats, and sunglasseschildren under 6 months of age: Ask a doctor

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water, Propylene Glycol, Glycerin, Isononyl Isononanoate, Dimethicone, Steareth-2, Ascorbyl Glucoside, Ethylhexyl Palmitate, Styrene/Acrylates Copolymer, Butyrospermum Parkii (Shea) Butter, Methyl Methacrylate Crosspolymer, Hexylresorcinol, Steareth-21, Behenyl Alcohol, Dimethicone Crosspolymer, Phenoxyethanol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Sodium Hydroxide, Caprylyl Glycol, Sclerotium Gum, Fragrance, Mica, Titanium Dioxide, Methylparaben, Disodium EDTA, Ethylparaben, Propylparaben

QUESTIONS?

OTC - QUESTIONS SECTION

Call 1-800-RoC-1964 (1-800-762-1964); Outside US, dial collect 215-273-8755, or visit ww.rocskincare.com

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73496-002-012022-01-28C16284748780-1d6a99b39-b9a5-a426-e053-dadaa90af4c2ROC MULTI CORREXION 5 IN 1 DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73496-002-01ROC MULTI CORREXION 5 IN 1 DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF3050 mL in 1 BOTTLELOTION501
73496-002-01ROC MULTI CORREXION 5 IN 1 DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF301 in 1 CARTONLOTION11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73496-002ROC MULTI CORREXION 5 IN 1 DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE) LOTION [ROC SKINCARE]1Legacy NDC, 2 package rows20191207_95ec5259-4888-45df-8c13-b47b7269d50b.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73496-00273496-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
WATER059QF0KO0RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
ISONONYL ISONONANOATES4V5BS6GCXIACT
DIMETHICONE92RU3N3Y1OIACT
STEARETH-2V56DFE46J5IACT
ASCORBYL GLUCOSIDE2V52R0NHXWIACT
ETHYLHEXYL PALMITATE2865993309IACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
SHEA BUTTERK49155WL9YIACT
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMEREG97988M5QIACT
HEXYLRESORCINOLR9QTB5E82NIACT
STEARETH-2153J3F32P58IACT
DOCOSANOL9G1OE216XYIACT
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE)UF7620L1W6IACT
PHENOXYETHANOLHIE492ZZ3TIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
SODIUM HYDRIDE23J3BHR95OIACT
CAPRYLYL GLYCOL00YIU5438UIACT
BETASIZOFIRAN2X51AD1X3TIACT
MICAV8A1AW0880IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
METHYLPARABENA2I8C7HI9TIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
ETHYLPARABEN14255EXE39IACT
PROPYLPARABENZ8IX2SC1OHIACT

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
890d244b-9e69-4d8d-94e6-5895f7982cf795ec5259-4888-45df-8c13-b47b7269d50b2019-12-04WarningsExact identifier
spl id: 890d244b-9e69-4d8d-94e6-5895f7982cf7
spl set id: 95ec5259-4888-45df-8c13-b47b7269d50b

Reported adverse events (FAERS/openFDA)#

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