ROC RETINOL CORREXION WRINKLE CORRECT DAILY MOISTURIZER SPF 30- avobenzone, homosalate, octisalate 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, Amcol Health & Beauty Solutions, Incorporated, Dermaceutical Laboratories Limited Liability Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Avobenzone 3.0%, Homosalate 10.0%, Octisalate 5.0 %.......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 a Poison Control Center right away.

KEEP OUT OF REACH OF CHILDREN

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 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, freezing and direct sun
• May stain some fabrics
• Store between 20-25 °C (68-77 °F)

INACTIVE INGREDIENT

Water, Glycerin, Diethylhexyl 2,6-Naphthalate, Dimethicone, Tetrahydroxypropyl Ethylenediamine, Butylene Glycol, Cyclohexasiloxane, Cetyl Alcohol, Butyrospermum Parkii (Shea) Butter, PPG-2 Myristyl Ether Propionate, Pentaerythrityl Tetraethylhexanoate, Squalane, Propanediol, Styrene/Acrylates Copolymer, Glyceryl Stearate, Aluminum Starch Octenylsuccinate, Retinol, Glycolic Acid, Tocopheryl Acetate, Ascorbyl Palmitate, Allantoin, p-Anisic Acid, Pentylene Glycol, Ceteth-20, Steareth-20, Polyacrylamide, PEG-8 Laurate, Laureth-7, C13-14 Isoparaffin, Ammonium Acryloyldimethyltaurate/VP Copolymer, PEG-75 Stearate, Cyclopentasiloxane, Polysorbate 20, Ascorbic Acid, Hydroxyphenyl Propamidobenzoic Acid, Caprylhydroxamic Acid, 1,2-Hexanediol, BHT, Disodium EDTA, Sodium Hydroxide, Fragrance.

Questions or Comments?

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

INDICATIONS & USAGE

• 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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73496-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 mg  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 mg  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 mg  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETOL (UNII: Q4R969U9FR)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
CETETH-20 (UNII: I835H2IHHX)
LAURETH-7 (UNII: Z95S6G8201)
WATER (UNII: 059QF0KO0R)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
SHEA BUTTER (UNII: K49155WL9Y)
SQUALANE (UNII: GW89575KF9)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
GLYCOLIC ACID (UNII: 0WT12SX38S)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)
CETYL ALCOHOL (UNII: 936JST6JCN)
ALLANTOIN (UNII: 344S277G0Z)
PEG-8 LAURATE (UNII: 762O8IWA10)
PEG-75 STEARATE (UNII: OT38R0N74H)
PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A)
PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897)
PROPANEDIOL (UNII: 5965N8W85T)
RETINOL (UNII: G2SH0XKK91)
P-ANISIC ACID (UNII: 4SB6Y7DMM3)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
C13-14 ISOPARAFFIN (UNII: E4F12ROE70)
AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
STEARETH-20 (UNII: L0Q8IK9E08)
POLYSORBATE 20 (UNII: 7T1F30V5YH)
ASCORBIC ACID (UNII: PQ6CK8PD0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GLYCERIN (UNII: PDC6A3C0OX)
DIMETHICONE (UNII: 92RU3N3Y1O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73496-004-01	30 mL in 1 TUBE; Type 0: Not a Combination Product	04/05/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	04/02/2021

Labeler - Roc Skincare (117157981)

Establishment
Name	Address	ID/FEI	Business Operations
Dermaceutical Laboratories Limited Liability Company		078457159	manufacture(73496-004)

Establishment
Name	Address	ID/FEI	Business Operations
Amcol Health & Beauty Solutions, Incorporated		872684803	manufacture(73496-004)