Label: ROC RETINOL CORREXION DEEP WRINKLE DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 30- avobenzone, homosalate, octocrylene, oxybenzone lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 73496-001-01 - 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 4, 2019
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PRINCIPAL DISPLAY PANEL
PACKAGE LABEL PRINCIPAL DISPLAY PANEL
OTC - PURPOSE
Active ingredientsPurposeAvobenzone (3%)SunscreenHomosalate (10%)SunscreenOctocrylene (3%)SunscreenOxybenzone (5%)Sunscreen
ROC 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, Glycerin, Tetrahydroxypropyl Ethylenediamine, Dimethicone, Butylene Glycol, Cyclohexasiloxane, Cetyl Alcohol, Butyrospermum Parkii (Shea) Butter, Squalane, PPG-2 Myristyl Ether Propionate, Pentaerythrityl Tetraethylhexanoate, Styrene/Acrylates Copolymer, Diethylhexyl 2,6-Naphthalate, Aluminum Starch Octenylsuccinate, Glyceryl Stearate, PEG-75 Stearate, Polyacrylamide, Glycolic Acid, Phenoxyethanol, Pentylene Glycol, Ammonium Acryloyldimethyltaurate/VP Copolymer, C13-14 Isoparaffin, Ceteth-20, Steareth-20, Methylparaben, Tocopheryl Acetate, Fragrance, Propylparaben, Ethylparaben, Laureth-7, BHT, Disodium EDTA, Cyclopentasiloxane, p-Anisic Acid, Allantoin, Polysorbate 20, Retinol, Ascorbic Acid, Hydroxyphenyl Propamidobenzoic Acid, Sodium Hydroxide
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INGREDIENTS AND APPEARANCE
ROC RETINOL CORREXION DEEP WRINKLE DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF 30
avobenzone, homosalate, octocrylene, oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73496-001 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE 30 mg in 1 mL HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE 100 mg in 1 mL OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 30 mg in 1 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 50 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) EDETOL (UNII: Q4R969U9FR) DIMETHICONE (UNII: 92RU3N3Y1O) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) CYCLOMETHICONE 6 (UNII: XHK3U310BA) CETYL ALCOHOL (UNII: 936JST6JCN) SHEA BUTTER (UNII: K49155WL9Y) SQUALENE (UNII: 7QWM220FJH) PPG-2 MYRISTYL ETHER PROPIONATE (UNII: 88R97D8U8A) PENTAERYTHRITYL TETRAETHYLHEXANOATE (UNII: XJ7052W897) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW) (UNII: 5Z4DPO246A) DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) PEG-75 STEARATE (UNII: OT38R0N74H) POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV) GLYCOLIC ACID (UNII: 0WT12SX38S) PHENOXYETHANOL (UNII: HIE492ZZ3T) PENTYLENE GLYCOL (UNII: 50C1307PZG) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) C13-14 ISOPARAFFIN (UNII: E4F12ROE70) CETETH-20 (UNII: I835H2IHHX) STEARETH-20 (UNII: L0Q8IK9E08) METHYLPARABEN (UNII: A2I8C7HI9T) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) PROPYLPARABEN (UNII: Z8IX2SC1OH) ETHYLPARABEN (UNII: 14255EXE39) LAURETH-7 (UNII: Z95S6G8201) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) P-ANISIC ACID (UNII: 4SB6Y7DMM3) ALLANTOIN (UNII: 344S277G0Z) POLYSORBATE 20 (UNII: 7T1F30V5YH) RETINOL (UNII: G2SH0XKK91) ASCORBIC ACID (UNII: PQ6CK8PD0R) HYDROXYPHENYL PROPAMIDOBENZOIC ACID (UNII: 25KRT26H77) SODIUM HYDROXIDE (UNII: 55X04QC32I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73496-001-01 1 in 1 CARTON 08/28/2012 1 30 mL in 1 TUBE; 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 08/28/2012 Labeler - ROC Skincare (117157981) Registrant - ROC Skincare (117157981) Establishment Name Address ID/FEI Business Operations Janssen Cilag 265148168 manufacture(73496-001)