ROC MULTI CORREXION 5-In-1 Daily Moisturizer With Sunscreen Broad Spectrum SPF 30

ROC MULTI CORREXION 5-In-1 Daily Moisturizer With Sunscreen Broad Spectrum SPF 30 by

Drug Labeling and Warnings

ROC MULTI CORREXION 5-In-1 Daily Moisturizer With Sunscreen Broad Spectrum SPF 30 by is a Otc medication manufactured, distributed, or labeled by Roc Skincare, Dermaceutical Laboratories Limited Liability Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ROC MULTI CORREXION 5-IN-1 DAILY MOISTURIZER WITH SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, homosalata, 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 With Sunscreen Broad Spectrum SPF 30

Avobenzone 2.0%, Homosalate 4.0%, Octisalate 4.0%, Octocrylene 2.0%.......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 Poison Control Center right away

Keep out of reach of children.

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 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

Water/Aqua/Eau, Niacinamide, Propylene Glycol, Glycerin, Isononyl Isononanoate, Dimethicone, Steareth-2, Ascorbyl Glucoside, Ethylhexyl Palmitate, Propanediol, Styrene/Acrylates Copolymer, Butyrospermum Parkii (Shea) Butter, Behenyl Alcohol, Hexylresorcinol, Steareth-21, Dimethicone Crosspolymer, Ammonium Acryloyldimethyltaurate/VP Copolymer, Sclerotium Gum, Caprylhydroxamic Acid, 1,2-Hexanediol, Sodium Hydroxide, Disodium EDTA, Titanium Dioxide (CI77891), Mica (CI 77019), Fragrance/Parfum.

Questions or Comments?

Call toll free 1-800-RoC-1964 (1-800-762-1964) or 215-273-8755 (collect).

ROC MULTI CORREXION 5-IN-1 DAILY MOISTURIZER WITH SUNSCREEN BROAD SPECTRUM SPF 30 
avobenzone, homosalata, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73496-006
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	4 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4 mg  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 mg  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
DOCOSANOL (UNII: 9G1OE216XY)
DIMETHICONE (UNII: 92RU3N3Y1O)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HEXYLRESORCINOL (UNII: R9QTB5E82N)
PROPANEDIOL (UNII: 5965N8W85T)
WATER (UNII: 059QF0KO0R)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-21 (UNII: 53J3F32P58)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
PEG-8 LAURATE (UNII: 762O8IWA10)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
ASCORBYL GLUCOSIDE (UNII: 2V52R0NHXW)
SHEA BUTTER (UNII: K49155WL9Y)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
MICA (UNII: V8A1AW0880)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
EDETATE DISODIUM (UNII: 7FLD91C86K)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
NIACINAMIDE (UNII: 25X51I8RD4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73496-006-01	50 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/01/2021	12/31/2022

Labeler - Roc Skincare (117157981)

Establishment
Name	Address	ID/FEI	Business Operations
Dermaceutical Laboratories Limited Liability Company		078457159	manufacture(73496-006)

Revised: 12/2022

Document Id: f0710a0a-9590-ea65-e053-2a95a90ae6f9

34390-5

Set id: d4780e38-4b13-1d0a-e053-2a95a90a7358

Version: 2

Effective Time: 20221222

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