ROC RETINOL CORREXION WRINKLE CORRECT DAILY MOISTURIZER SPF 30- avobenzone, homosalate, octisalate, octocrylene lotion

RoC Retinol Correxion Wrinkle Correct Daily Moisturizer SPF 30 by

Drug Labeling and Warnings

RoC Retinol Correxion Wrinkle Correct Daily Moisturizer 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]

Active ingredients

Active ingredients Purpose

Avobenzone 3.0%, Homosalate 6.6%, Octisalate 5.0%, Octocrylene 2.0% Sunscreen

Uses

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

Purpose

Purpose

Sunscreen

Warnings

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.

Keep out of reach of children

Keep out of reach of children.

Directions for Sunscreen use

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

Other information Begin applying this product every other day and then gradually increase frequency to every day. You may experience a slight tingling or tightness during use. This is normal and should be temporary until your skin adjusts. Discontinue use if skin irritation develops and lasts. Protect from excessive heat (40°C/104°F).

Inactive ingredients

Inactive ingredients Water/Aqua/Eau, Glycerin, Diethylhexyl 2,6-Naphthalate, Dimethicone, Isododecane, Tetrahydroxypropyl Ethylenediamine, Cetyl Alcohol, Butylene Glycol, Butyrospermum Parkii (Shea) Butter, PPG-2 Myristyl Ether Propionate, Squalane, Styrene/Acrylates Copolymer, Glyceryl Stearate, Aluminum Starch Octenylsuccinate, Propanediol, Retinol, Allantoin, Aloe Barbadensis Leaf Juice, Glycolic Acid, Ceteth-20, p-Anisic Acid, Polyacrylamide, Ammonium Acryloyldimethyltaurate/VP Copolymer, C13-14 Isoparaffin, Steareth-20, Tocopheryl Acetate, PEG-8 Laurate, Laureth-7, BHT, Polysorbate 20, Ascorbic Acid, Potassium Sorbate, Disodium EDTA, 1,2-Hexanediol, Sodium Hydroxide, Citric Acid, Caprylhydroxamic Acid, Sodium Benzoate, Fragrance/Parfum.

Questions or Comments?

Questions or Comments?
Call toll free 1-800-RoC-1964 (1-800-762-1964).

Artwork Label

INGREDIENTS AND APPEARANCE

ROC RETINOL CORREXION WRINKLE CORRECT DAILY MOISTURIZER SPF 30 
avobenzone, homosalate, octisalate, octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73496-009
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 mg  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	6.6 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BHT (UNII: 1P9D0Z171K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
SODIUM BENZOATE (UNII: OJ245FE5EU)
PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
STEARETH-20 (UNII: L0Q8IK9E08)
ISODODECANE (UNII: A8289P68Y2)
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PEG-8 LAURATE (UNII: 762O8IWA10)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
CITRIC ACID (UNII: 2968PHW8QP)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
GLYCOLIC ACID (UNII: 0WT12SX38S)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
LAURETH-7 (UNII: Z95S6G8201)
TETRAHYDROXYPROPYL ETHYLENEDIAMINE (UNII: Q4R969U9FR)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
DIMETHICONE (UNII: 92RU3N3Y1O)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
ALOE BARBADENSIS LEAF JUICE (UNII: ZY81Z83H0X)
CETETH-20 (UNII: I835H2IHHX)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CETYL ALCOHOL (UNII: 936JST6JCN)
POLYACRYLAMIDE (10000 MW) (UNII: E2KR9C9V2I)
SHEA BUTTER (UNII: K49155WL9Y)
SQUALANE (UNII: GW89575KF9)
STYRENE/ACRYLAMIDE COPOLYMER (MW 500000) (UNII: 5Z4DPO246A)
GLYCERYL STEARATE (UNII: 230OU9XXE4)
PROPANEDIOL (UNII: 5965N8W85T)
RETINOL (UNII: G2SH0XKK91)
ALLANTOIN (UNII: 344S277G0Z)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73496-009-00	30 mL in 1 TUBE; Type 0: Not a Combination Product	10/01/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/01/2024

Labeler - RoC Skincare (117157981)

Establishment
Name	Address	ID/FEI	Business Operations
Dermaceutical Laboratories Limited Liability Company		078457159	manufacture(73496-009)