ROC RETINOL CORREXION DEEP WRINKLE DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF30- avobenzone, homosalate, octocrylene, and oxybenzone lotion

RoC Retinol Correxion Deep Wrinkle Daily Moisturizer by

Drug Labeling and Warnings

RoC Retinol Correxion Deep Wrinkle Daily Moisturizer by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Sante' Beaute', France(. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

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

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

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

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

Directions

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

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

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

PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton

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)

INGREDIENTS AND APPEARANCE

ROC RETINOL CORREXION DEEP WRINKLE DAILY MOISTURIZER   SUNSCREEN BROAD SPECTRUM SPF30
avobenzone, homosalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53738-0711
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
Allantoin (UNII: 344S277G0Z)
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)
Ascorbic Acid (UNII: PQ6CK8PD0R)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
Butylene Glycol (UNII: 3XUS85K0RA)
SHEA BUTTER (UNII: K49155WL9Y)
C13-14 Isoparaffin (UNII: E4F12ROE70)
Ceteth-20 (UNII: I835H2IHHX)
Cetyl Alcohol (UNII: 936JST6JCN)
Cyclomethicone 6 (UNII: XHK3U310BA)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)
Dimethicone (UNII: 92RU3N3Y1O)
Edetate Disodium (UNII: 7FLD91C86K)
Ethylparaben (UNII: 14255EXE39)
Glycerin (UNII: PDC6A3C0OX)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Glycolic Acid (UNII: 0WT12SX38S)
Hydroxyphenyl Propamidobenzoic Acid (UNII: 25KRT26H77)
Laureth-7 (UNII: Z95S6G8201)
Methylparaben (UNII: A2I8C7HI9T)
p-Anisic Acid (UNII: 4SB6Y7DMM3)
PEG-75 Stearate (UNII: OT38R0N74H)
Pentaerythrityl Tetraethylhexanoate (UNII: XJ7052W897)
Pentylene Glycol (UNII: 50C1307PZG)
Phenoxyethanol (UNII: HIE492ZZ3T)
Polysorbate 20 (UNII: 7T1F30V5YH)
PPG-2 Myristyl Ether Propionate (UNII: 88R97D8U8A)
Propylparaben (UNII: Z8IX2SC1OH)
Retinol (UNII: G2SH0XKK91)
Sodium Hydroxide (UNII: 55X04QC32I)
Squalane (UNII: GW89575KF9)
Steareth-20 (UNII: L0Q8IK9E08)
Edetol (UNII: Q4R969U9FR)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53738-0711-1	1 in 1 CARTON	08/28/2012
1		30 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 53738-0711-2	1 in 1 CARTON	08/28/2012
2		33 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 - Johnson & Johnson Sante' Beaute', France( (276417800)