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

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

Drug Labeling and Warnings

Roc Retinol Correxion Deep Wrinkle Daily Moisturizer Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by ROC Skincare, Janssen Cilag. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL PRINCIPAL DISPLAY PANEL

OTC - PURPOSE

Active ingredientsPurposeAvobenzone (3%)SunscreenHomosalate (10%)SunscreenOctocrylene (3%)SunscreenOxybenzone (5%)Sunscreen 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

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73496-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	30 mg  in 1 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73496-001-01	1 in 1 CARTON	08/28/2012
1		30 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	08/28/2012

Labeler - ROC Skincare (117157981)

Registrant - ROC Skincare (117157981)

Establishment
Name	Address	ID/FEI	Business Operations
Janssen Cilag		265148168	manufacture(73496-001)