Label: ROC RETINOL CORREXION WRINKLE CORRECT DAILY MOISTURIZER SPF 30- avobenzone, homosalate, octisalate lotion
- Label RSS
- Share
- NDC Code(s): 73496-004-01
- Packager: Roc Skincare
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Drug Label Information
Updated December 22, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Uses
- Warnings
- 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
-
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?
-
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 lotionProduct 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 not final part352 04/02/2021 Labeler - Roc Skincare (117157981) Establishment Name Address ID/FEI Business Operations Amcol Health & Beauty Solutions, Incorporated 872684803 manufacture(73496-004) Establishment Name Address ID/FEI Business Operations Dermaceutical Laboratories Limited Liability Company 078457159 manufacture(73496-004)
