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

PACKAGE LABEL PRINCIPAL DISPLAY PANELROC MULTI CORREXION 5 IN 1 DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF30.jpg

OTC - PURPOSE

Active ingredientsPurposeAvobenzone (2%)SunscreenHomosalate (4%)SunscreenOctisalate (4%)SunscreenOctocrylene (2%)SunscreenROC MULTI CORREXION 5 IN 1 DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF30.jpg

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, 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?

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

ROC MULTI CORREXION 5 IN 1 DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF30 
avobenzone, homosalate, octisalate, octocrylene lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73496-002
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE20 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE40 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE40 mg  in 1 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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)  
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)  
SHEA BUTTER (UNII: K49155WL9Y)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
HEXYLRESORCINOL (UNII: R9QTB5E82N)  
STEARETH-21 (UNII: 53J3F32P58)  
DOCOSANOL (UNII: 9G1OE216XY)  
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)  
SODIUM HYDRIDE (UNII: 23J3BHR95O)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
BETASIZOFIRAN (UNII: 2X51AD1X3T)  
MICA (UNII: V8A1AW0880)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
ETHYLPARABEN (UNII: 14255EXE39)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73496-002-011 in 1 CARTON03/01/2013
150 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35203/01/2013
Labeler - ROC Skincare (117157981)
Registrant - ROC Skincare (117157981)
Establishment
NameAddressID/FEIBusiness Operations
Janssen Cilag265148168manufacture(73496-002)

Revised: 12/2019
Document Id: 890d244b-9e69-4d8d-94e6-5895f7982cf7
Set id: 95ec5259-4888-45df-8c13-b47b7269d50b
Version: 1
Effective Time: 20191204
 
ROC Skincare