FDA.reportPublic FDA data

Avobenzone, Homosalate, Octocrylene, Oxybenzone

Manufacturer
ROC Skincare | Janssen Cilag
Effective date
2019-12-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:01:45

Label at a glance#

ProductRoc Retinol Correxion Deep Wrinkle Daily Moisturizer Sunscreen Broad Spectrum SPF 30
Active ingredientAVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE
Label structure1 sections

Label contents#

Full prescribing information#

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL PRINCIPAL DISPLAY PANELROC RETINOL CORREXION DEEP WRINKLE DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF30.jpgROC RETINOL CORREXION DEEP WRINKLE DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF30.jpg

OTC - PURPOSE

OTC - PURPOSE SECTION

Active ingredientsPurposeAvobenzone (3%)SunscreenHomosalate (10%)SunscreenOctocrylene (3%)SunscreenOxybenzone (5%)SunscreenROC RETINOL CORREXION DEEP WRINKLE DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF30.jpgROC RETINOL CORREXION DEEP WRINKLE DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF30.jpg ROC 

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, Glycerin, Tetrahydroxypropyl Ethylenediamine, Dimethicone, Butylene Glycol, Cyclohexasiloxane, Cetyl Alcohol, Butyrospermum Parkii (Shea) Butter, Squalane, PPG-2 Myristyl Ether Propionate, Pentaerythrityl Tetraethylhexanoate, Styrene/Acrylates Copolymer, Diethylhexyl 2,6-Naphthalate, Aluminum Starch Octenylsuccinate, Glyceryl Stearate, PEG-75 Stearate, Polyacrylamide, Glycolic Acid, Phenoxyethanol, Pentylene Glycol, Ammonium Acryloyldimethyltaurate/VP Copolymer, C13-14 Isoparaffin, Ceteth-20, Steareth-20, Methylparaben, Tocopheryl Acetate, Fragrance, Propylparaben, Ethylparaben, Laureth-7, BHT, Disodium EDTA, Cyclopentasiloxane, p-Anisic Acid, Allantoin, Polysorbate 20, Retinol, Ascorbic Acid, Hydroxyphenyl Propamidobenzoic Acid, Sodium Hydroxide

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73496-001-012022-01-28C16284748780-1d6a99b39-d2b1-a426-e053-dadaa90af4c2Roc Retinol Correxion Deep Wrinkle Daily Moisturizer Sunscreen Broad Spectrum SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73496-001-01Roc Retinol Correxion Deep Wrinkle Daily Moisturizer Sunscreen Broad Spectrum SPF 301 in 1 CARTONLOTION12
73496-001-01Roc Retinol Correxion Deep Wrinkle Daily Moisturizer Sunscreen Broad Spectrum SPF 3030 mL in 1 TUBELOTION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73496-001ROC RETINOL CORREXION DEEP WRINKLE DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTOCRYLENE, OXYBENZONE) LOTION [ROC SKINCARE]2Legacy NDC, 2 package rows20191206_1ece3d57-b96d-49a3-93ad-8e8fa67d5e24.zip

Products#

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

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73496-00173496-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 43 matching rows.

Name, UNII, Kind table
NameUNIIKind
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
EDETOLQ4R969U9FRIACT
DIMETHICONE92RU3N3Y1OIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
CYCLOMETHICONE 6XHK3U310BAIACT
CETYL ALCOHOL936JST6JCNIACT
SHEA BUTTERK49155WL9YIACT
SQUALENE7QWM220FJHIACT
PPG-2 MYRISTYL ETHER PROPIONATE88R97D8U8AIACT
PENTAERYTHRITYL TETRAETHYLHEXANOATEXJ7052W897IACT
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)5Z4DPO246AIACT
DIETHYLHEXYL 2,6-NAPHTHALATEI0DQJ7YGXMIACT
ALUMINUM STARCH OCTENYLSUCCINATEI9PJ0O6294IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-75 STEARATEOT38R0N74HIACT
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT
GLYCOLIC ACID0WT12SX38SIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PENTYLENE GLYCOL50C1307PZGIACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
CETETH-20I835H2IHHXIACT
STEARETH-20L0Q8IK9E08IACT
METHYLPARABENA2I8C7HI9TIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PROPYLPARABENZ8IX2SC1OHIACT
ETHYLPARABEN14255EXE39IACT
LAURETH-7Z95S6G8201IACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
CYCLOMETHICONE 50THT5PCI0RIACT
P-ANISIC ACID4SB6Y7DMM3IACT
ALLANTOIN344S277G0ZIACT
POLYSORBATE 207T1F30V5YHIACT
RETINOLG2SH0XKK91IACT

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
f092ad13-5c73-471c-892c-440fba1063bd1ece3d57-b96d-49a3-93ad-8e8fa67d5e242019-12-04WarningsExact identifier
spl id: f092ad13-5c73-471c-892c-440fba1063bd
spl set id: 1ece3d57-b96d-49a3-93ad-8e8fa67d5e24

Reported adverse events (FAERS/openFDA)#

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