ROC MULTI CORREXION 5 IN 1 MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF30- avobenzone, homosalate, octisalate, and octocrylene lotion

RoC Multi Correxion 5 in 1 Moisturizer by

Drug Labeling and Warnings

RoC Multi Correxion 5 in 1 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 (2%)	Sunscreen
Homosalate (4%)	Sunscreen
Octisalate (4%)	Sunscreen
Octocrylene (2%)	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 evenly 15 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 and direct sun
• may stain some fabrics

Inactive ingredients

Water, Propylene Glycol, Glycerin, Isononyl Isononanoate, Dimethicone, Steareth-2, Ascorbyl Glucoside, Ethylhexyl Palmitate, Styrene/Acrylates Copolymer, Butyrospermum Parkii (Shea) Butter, Methyl Methacrylate Crosspolymer, Hexylresorcinol, Steareth-21, Behenyl Alcohol, Dimethicone Crosspolymer, Phenoxyethanol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Sodium Hydroxide, Caprylyl Glycol, Sclerotium Gum, Fragrance, Mica, Titanium Dioxide, Methylparaben, Disodium EDTA, Ethylparaben, Propylparaben

Questions or comments?

Call toll free 800-762-1964 or 215-273-8755 (collect) or visit www.rocskincare.com

PRINCIPAL DISPLAY PANEL - 50 mL Bottle Carton

RoC®

WE KEEP OUR PROMISES®

NEW

MULTI CORREXION®
5 IN 1
DAILY MOISTURIZER

with
SUNSCREEN
BROAD SPECTRUM SPF 30

Improves the look of
discoloration, sagging, dryness,
dull tone, and wrinkles

HEXINOL™ Technology

Rendering is 84% of actual size

1.7 fl oz (50 mL)

INGREDIENTS AND APPEARANCE

ROC MULTI CORREXION 5 IN 1 MOISTURIZER   SUNSCREEN BROAD SPECTRUM SPF30
avobenzone, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53738-0713
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	20 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	40 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	40 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)
Glycerin (UNII: PDC6A3C0OX)
Isononyl Isononanoate (UNII: S4V5BS6GCX)
Dimethicone (UNII: 92RU3N3Y1O)
Steareth-2 (UNII: V56DFE46J5)
Ascorbyl Glucoside (UNII: 2V52R0NHXW)
Ethylhexyl Palmitate (UNII: 2865993309)
Shea Butter (UNII: K49155WL9Y)
Hexylresorcinol (UNII: R9QTB5E82N)
Steareth-21 (UNII: 53J3F32P58)
Docosanol (UNII: 9G1OE216XY)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG)
Sodium Hydroxide (UNII: 55X04QC32I)
Caprylyl Glycol (UNII: 00YIU5438U)
Betasizofiran (UNII: 2X51AD1X3T)
Mica (UNII: V8A1AW0880)
Titanium Dioxide (UNII: 15FIX9V2JP)
Methylparaben (UNII: A2I8C7HI9T)
Edetate Disodium (UNII: 7FLD91C86K)
Ethylparaben (UNII: 14255EXE39)
Propylparaben (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53738-0713-0	1 in 1 CARTON
1		50 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	03/01/2013

Labeler - Johnson & Johnson Sante Beaute- France (276417800)