ROC RETINOL CORREXION DEEP WRINKLE DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octocrylene, oxybenzone lotion 
ROC Skincare

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Roc Retinol Correxion Deep Wrinkle Daily Moisturizer Sunscreen Broad Spectrum SPF 30

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

OTC - PURPOSE

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

OTC - KEEP OUT OF REACH OF CHILDREN

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

USES

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

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

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

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?

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

ROC RETINOL CORREXION DEEP WRINKLE DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 30 
avobenzone, homosalate, octocrylene, oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73496-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE30 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE50 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
EDETOL (UNII: Q4R969U9FR)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
CYCLOMETHICONE 6 (UNII: XHK3U310BA)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
SHEA BUTTER (UNII: K49155WL9Y)  
SQUALENE (UNII: 7QWM220FJH)  
PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)  
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)  
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-75 STEARATE (UNII: OT38R0N74H)  
POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
PENTYLENE GLYCOL (UNII: 50C1307PZG)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
CETETH-20 (UNII: I835H2IHHX)  
STEARETH-20 (UNII: L0Q8IK9E08)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
ETHYLPARABEN (UNII: 14255EXE39)  
LAURETH-7 (UNII: Z95S6G8201)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
P-ANISIC ACID (UNII: 4SB6Y7DMM3)  
ALLANTOIN (UNII: 344S277G0Z)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
RETINOL (UNII: G2SH0XKK91)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73496-001-011 in 1 CARTON08/28/2012
130 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35208/28/2012
Labeler - ROC Skincare (117157981)
Registrant - ROC Skincare (117157981)
Establishment
NameAddressID/FEIBusiness Operations
Janssen Cilag265148168manufacture(73496-001)

Revised: 12/2019
Document Id: f092ad13-5c73-471c-892c-440fba1063bd
Set id: 1ece3d57-b96d-49a3-93ad-8e8fa67d5e24
Version: 2
Effective Time: 20191204
 
ROC Skincare