ROC MULTI CORREXION 5 IN 1 CHEST, NECK AND FACE SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octisalate, octocrylene lotion

ROC MULTI CORREXION 5 IN 1 CHEST, NECK AND FACE SUNSCREEN BROAD SPECTRUM SPF 30 by

Drug Labeling and Warnings

ROC MULTI CORREXION 5 IN 1 CHEST, NECK AND FACE SUNSCREEN BROAD SPECTRUM SPF 30 by is a Otc medication manufactured, distributed, or labeled by ROC Skincare, Vee Pak LLC/Voyant Beauty. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 

OTC - PURPOSE

Active ingredientsPurpose

Avobenzone 2% Sunscreen Homosalate 4% Sunscreen Octisalate 4% Sunscreen Octocrylene 2% Sunscreen

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, Ethylhexyl Palmitate, Styrene/Acrylates Copolymer, Butyrospermum Parkii (Shea) Butter, Vinyl Dimethicone/Methicone Silsesquioxane Crosspolymer, Hexylresorcinol, Steareth-21, Ammonium Acryloyldimethyltaurate/VP Copolymer, Behenyl Alcohol, Phenoxyethanol, Dimethicone Crosspolymer, Ascorbyl Glucoside, Sclerotium Gum, Chlorphenesin, Fragrance, Disodium EDTA, Tocopheryl Acetate, Maltodextrin, Ethylhexylglycerin, Sodium Hydroxide, Butylene Glycol, Peucedanum Graveolens (Dill) Extract, Rubus Fruticosus (Blackberry) Leaf Extract, Xanthan Gum

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 MULTI CORREXION 5 IN 1 CHEST, NECK AND FACE SUNSCREEN BROAD SPECTRUM SPF 30 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73496-003
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 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	40 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	40 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	20 mg  in 1 g

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)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A)
SHEA BUTTER (UNII: K49155WL9Y)
VINYL DIMETHICONE/METHICONE SILSESQUIOXANE CROSSPOLYMER (UNII: 9NH1UDD2RR)
HEXYLRESORCINOL (UNII: R9QTB5E82N)
STEARETH-21 (UNII: 53J3F32P58)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
DOCOSANOL (UNII: 9G1OE216XY)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
CHLORPHENESIN (UNII: I670DAL4SZ)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
DILL (UNII: Y05PC4JZRH)
RUBUS FRUTICOSUS LEAF (UNII: YQ2S06L8S9)
XANTHAN GUM (UNII: TTV12P4NEE)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73496-003-01	1 in 1 CARTON	09/01/2015
1		48 g in 1 JAR; 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	09/01/2015

Labeler - ROC Skincare (117157981)

Registrant - ROC Skincare (117157981)

Establishment
Name	Address	ID/FEI	Business Operations
Vee Pak LLC/Voyant Beauty		080578923	manufacture(73496-003)