FDA.reportPublic FDA data

RoC Retinol Correxion Deep Wrinkle Daily Moisturizer

Manufacturer
Johnson & Johnson Sante' Beaute', France(
Effective date
2020-08-13
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 23:18:27

Label at a glance#

ProductRoC Retinol Correxion Deep Wrinkle Daily Moisturizer Sunscreen Broad Spectrum SPF30
Active ingredientAvobenzone, Homosalate, Octocrylene, Oxybenzone
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

Dosage and administration

For sunscreen use: apply generously and evenly15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating 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: limi...

Storage and handling

protect this product from excessive heat, freezing and direct sun may stain some fabrics store between 68F (20C) and 77F (25C)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Avobenzone (3%)Sunscreen
Homosalate (10%)Sunscreen
Octocrylene (3%)Sunscreen
Oxybenzone (5%)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

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs

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

Directions

DOSAGE & ADMINISTRATION SECTION

For sunscreen use:

  • apply generously and evenly15 minutes before sun exposure
  • reapply at least every 2 hours
  • use a water resistant sunscreen if swimming or sweating
  • 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 a.m. – 2 p.m.
    • wear long-sleeved shirts, pants, hats, and sunglasses
  • children under 6 months of age: Ask a doctor

Other Information

STORAGE AND HANDLING SECTION

  • protect this product from excessive heat, freezing and direct sun
  • may stain some fabrics
  • store between 68F (20C) and 77F (25C)

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

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RoC®

WE KEEP OUR PROMISES®

RETINOL CORREXION®

DEEP WRINKLE
DAILY MOISTURIZER

WITH
SUNSCREEN
BROAD SPECTRUM SPF 30

Reduces the look of
expression lines and
deep wrinkles

1.0 fl oz (30 mL)

Principal Display Panel - 30 mL Tube Carton
Principal Display Panel - 30 mL Tube Carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AvobenzoneACTIVE INGREDIENTG63QQF2NOX1
HomosalateACTIVE INGREDIENTV06SV4M95S1
OctocryleneACTIVE INGREDIENT5A68WGF6WM1
OxybenzoneACTIVE INGREDIENT95OOS7VE0Y1
AvobenzoneACTIVE MOIETYG63QQF2NOX1
HomosalateACTIVE MOIETYV06SV4M95S1
OctocryleneACTIVE MOIETY5A68WGF6WM1
OxybenzoneACTIVE MOIETY95OOS7VE0Y1
.Alpha.-Tocopherol AcetateINACTIVE INGREDIENT9E8X80D2L01
AllantoinINACTIVE INGREDIENT344S277G0Z1
Aluminum Starch OctenylsuccinateINACTIVE INGREDIENTI9PJ0O62941
Ascorbic AcidINACTIVE INGREDIENTPQ6CK8PD0R1
BUTYLATED HYDROXYTOLUENEINACTIVE INGREDIENT1P9D0Z171K1
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RA1
C13-14 IsoparaffinINACTIVE INGREDIENTE4F12ROE701
Ceteth-20INACTIVE INGREDIENTI835H2IHHX1
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCN1
Cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0R1
Cyclomethicone 6INACTIVE INGREDIENTXHK3U310BA1
Diethylhexyl 2,6-NaphthalateINACTIVE INGREDIENTI0DQJ7YGXM1
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86K1
EdetolINACTIVE INGREDIENTQ4R969U9FR1
EthylparabenINACTIVE INGREDIENT14255EXE391
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE41
Glycolic AcidINACTIVE INGREDIENT0WT12SX38S1
Hydroxyphenyl Propamidobenzoic AcidINACTIVE INGREDIENT25KRT26H771
Laureth-7INACTIVE INGREDIENTZ95S6G82011
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T1
p-Anisic AcidINACTIVE INGREDIENT4SB6Y7DMM31
PEG-75 StearateINACTIVE INGREDIENTOT38R0N74H1
Pentaerythrityl TetraethylhexanoateINACTIVE INGREDIENTXJ7052W8971
Pentylene GlycolINACTIVE INGREDIENT50C1307PZG1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3T1
Polysorbate 20INACTIVE INGREDIENT7T1F30V5YH1
PPG-2 Myristyl Ether PropionateINACTIVE INGREDIENT88R97D8U8A1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OH1
RetinolINACTIVE INGREDIENTG2SH0XKK911
Sheanut OilINACTIVE INGREDIENTO88E196QRF1
Sodium HydroxideINACTIVE INGREDIENT55X04QC32I1
SqualaneINACTIVE INGREDIENTGW89575KF91
Steareth-20INACTIVE INGREDIENTL0Q8IK9E081
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 2 · 44 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53738-071153738-0711-1, 53738-0711-2

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 42 matching rows.

Name, UNII, Kind table
NameUNIIKind
AvobenzoneG63QQF2NOXACTIB
HomosalateV06SV4M95SACTIB
Octocrylene5A68WGF6WMACTIB
Oxybenzone95OOS7VE0YACTIB
Allantoin344S277G0ZIACT
Aluminum Starch OctenylsuccinateI9PJ0O6294IACT
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMERW59H9296ZGIACT
Ascorbic AcidPQ6CK8PD0RIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
Butylene Glycol3XUS85K0RAIACT
SHEA BUTTERK49155WL9YIACT
C13-14 IsoparaffinE4F12ROE70IACT
Ceteth-20I835H2IHHXIACT
Cetyl Alcohol936JST6JCNIACT
Cyclomethicone 6XHK3U310BAIACT
Cyclomethicone 50THT5PCI0RIACT
Diethylhexyl 2,6-NaphthalateI0DQJ7YGXMIACT
Dimethicone92RU3N3Y1OIACT
Edetate Disodium7FLD91C86KIACT
Ethylparaben14255EXE39IACT
GlycerinPDC6A3C0OXIACT
Glyceryl Monostearate230OU9XXE4IACT
Glycolic Acid0WT12SX38SIACT
Hydroxyphenyl Propamidobenzoic Acid25KRT26H77IACT
Laureth-7Z95S6G8201IACT
MethylparabenA2I8C7HI9TIACT
p-Anisic Acid4SB6Y7DMM3IACT
PEG-75 StearateOT38R0N74HIACT
Pentaerythrityl TetraethylhexanoateXJ7052W897IACT
Pentylene Glycol50C1307PZGIACT
PhenoxyethanolHIE492ZZ3TIACT
Polysorbate 207T1F30V5YHIACT
PPG-2 Myristyl Ether Propionate88R97D8U8AIACT
PropylparabenZ8IX2SC1OHIACT
RetinolG2SH0XKK91IACT
Sodium Hydroxide55X04QC32IIACT
SqualaneGW89575KF9IACT
Steareth-20L0Q8IK9E08IACT
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMERV5RS026Q0HIACT
EdetolQ4R969U9FRIACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 11 · 629 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GlycerinGLYCERINPDC6A3C0OXSYSTEM / TOPICAL18144 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRAVITREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / EPIDURAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHCAPSULE, EXTENDED RELEASE / ORAL0.22 mgExact identifier — unii candidate
68 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / RETROBULBARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KDROPS / NASAL0.1 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KSUPPOSITORY / VAGINALNAExact identifier — unii candidate
32 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHSUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
68 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHTABLET, FILM COATED / ORAL0.35 mgExact identifier — unii candidate
28 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, FOR SOLUTION / PARENTERALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IFILM, EXTENDED RELEASE / TRANSDERMAL0.85 mgExact identifier — unii candidate
174 equally ranked IID candidates
Glyceryl MonostearateGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / VAGINAL3 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION, CONCENTRATE / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUSADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / TRANSDERMAL306.2 mgExact identifier — unii candidate
75 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TELIXIR / ORAL800 mgExact identifier — unii candidate
79 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IGEL / VAGINAL20 mgExact identifier — unii candidate
174 equally ranked IID candidates
PhenoxyethanolPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IFILM, SOLUBLE / ORAL11 mgExact identifier — unii candidate
174 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KCAPSULE / ORAL5 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXEMULSION / OPHTHALMIC3 mgExact identifier — unii candidate
75 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHOINTMENT / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
.Alpha.-Tocopherol Acetate.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXINJECTION / INTRAVENOUS33750 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXPASTE / ORAL3822 mgExact identifier — unii candidate
75 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXCONCENTRATE / ORAL1800 mgExact identifier — unii candidate
75 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHTABLET, CHEWABLE / ORAL0.14 mgExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TJELLY / NASAL250 mgExact identifier — unii candidate
79 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXDROPS / NASAL10 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHLOTION / TOPICAL2000 mgExact identifier — unii candidate
28 equally ranked IID candidates
Cyclomethicone 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii candidate
3 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRACAVITARYADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHINJECTION, SUSPENSION / SUBCUTANEOUS0.02 %w/vExact identifier — unii candidate
68 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KINJECTION / INTRALESIONAL0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / IONTOPHORESISADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IPASTE / DENTAL0.6 %w/wExact identifier — unii candidate
174 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHCLOTH / TOPICALNAExact identifier — unii candidate
28 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / EXTRACORPOREALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / ENDOTRACHEALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IPOWDER, FOR SUSPENSION / ORAL9 mgExact identifier — unii candidate
174 equally ranked IID candidates
BUTYLATED HYDROXYTOLUENEBUTYLATED HYDROXYTOLUENE1P9D0Z171KINJECTION, POWDER, FOR SOLUTION / INTRAVENOUSNAExact identifier — unii candidate
32 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRAMUSCULARADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
EthylparabenETHYLPARABEN14255EXE39POWDER, FOR SOLUTION / ORAL13 mgExact identifier — unii candidate
4 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHTABLET, COATED / ORAL0.8 mgExact identifier — unii candidate
68 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNAEROSOL, FOAM / VAGINAL0.75 %w/wExact identifier — unii candidate
20 equally ranked IID candidates
Cetyl AlcoholCETYL ALCOHOL936JST6JCNTABLET, EXTENDED RELEASE / ORAL132 mgExact identifier — unii candidate
20 equally ranked IID candidates
Edetate DisodiumEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / RECTAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION/ DROPS / AURICULAR (OTIC)25 mgExact identifier — unii candidate
75 equally ranked IID candidates
PropylparabenPROPYLPARABENZ8IX2SC1OHOINTMENT / TOPICAL0.2 %w/wExact identifier — unii candidate
68 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TINJECTION / INFILTRATION80 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / RECTAL1808 mgExact identifier — unii candidate
79 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSUSPENSION / TOPICAL0.24 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISOLUTION / INTRA-ARTERIALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32IINJECTION / INTRABURSALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii candidate
75 equally ranked IID candidates
Sodium HydroxideSODIUM HYDROXIDE55X04QC32ISPONGE / TOPICALADJ PHExact identifier — unii candidate
174 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TCAPSULE / ORAL7 mgExact identifier — unii candidate
79 equally ranked IID candidates
Polysorbate 20POLYSORBATE 207T1F30V5YHSHAMPOO / TOPICAL8 %w/wExact identifier — unii candidate
28 equally ranked IID candidates

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
f84a183c-ef8c-4197-904e-70bd4300d5f3d0aa1998-633e-4a3e-8b3b-d80417b080db2020-08-13WarningsExact identifier
spl id: f84a183c-ef8c-4197-904e-70bd4300d5f3
spl set id: d0aa1998-633e-4a3e-8b3b-d80417b080db

Reported adverse events (FAERS/openFDA)#

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