NDC | 53738-0711-1, 53738-0711-2 |
Set ID | d0aa1998-633e-4a3e-8b3b-d80417b080db |
Category | HUMAN OTC DRUG LABEL |
Packager | Johnson & Johnson Sante' Beaute', France( |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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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
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Directions
For sunscreen use:
- apply generously and evenly15 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
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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
- Questions?
- PRINCIPAL DISPLAY PANEL - 30 mL Tube Carton
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INGREDIENTS AND APPEARANCE
ROC RETINOL CORREXION DEEP WRINKLE DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF30
avobenzone, homosalate, octocrylene, and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53738-0711 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 Allantoin (UNII: 344S277G0Z) Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294) AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER (UNII: W59H9296ZG) Ascorbic Acid (UNII: PQ6CK8PD0R) BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K) Butylene Glycol (UNII: 3XUS85K0RA) SHEA BUTTER (UNII: K49155WL9Y) C13-14 Isoparaffin (UNII: E4F12ROE70) Ceteth-20 (UNII: I835H2IHHX) Cetyl Alcohol (UNII: 936JST6JCN) Cyclomethicone 6 (UNII: XHK3U310BA) Cyclomethicone 5 (UNII: 0THT5PCI0R) Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM) Dimethicone (UNII: 92RU3N3Y1O) Edetate Disodium (UNII: 7FLD91C86K) Ethylparaben (UNII: 14255EXE39) Glycerin (UNII: PDC6A3C0OX) Glyceryl Monostearate (UNII: 230OU9XXE4) Glycolic Acid (UNII: 0WT12SX38S) Hydroxyphenyl Propamidobenzoic Acid (UNII: 25KRT26H77) Laureth-7 (UNII: Z95S6G8201) Methylparaben (UNII: A2I8C7HI9T) p-Anisic Acid (UNII: 4SB6Y7DMM3) PEG-75 Stearate (UNII: OT38R0N74H) Pentaerythrityl Tetraethylhexanoate (UNII: XJ7052W897) Pentylene Glycol (UNII: 50C1307PZG) Phenoxyethanol (UNII: HIE492ZZ3T) Polysorbate 20 (UNII: 7T1F30V5YH) PPG-2 Myristyl Ether Propionate (UNII: 88R97D8U8A) Propylparaben (UNII: Z8IX2SC1OH) Retinol (UNII: G2SH0XKK91) Sodium Hydroxide (UNII: 55X04QC32I) Squalane (UNII: GW89575KF9) Steareth-20 (UNII: L0Q8IK9E08) BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H) Edetol (UNII: Q4R969U9FR) .Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53738-0711-1 1 in 1 CARTON 08/28/2012 08/15/2022 1 30 mL in 1 TUBE; Type 0: Not a Combination Product 2 NDC:53738-0711-2 1 in 1 CARTON 08/28/2012 10/16/2022 2 33 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 10/16/2022 Labeler - Johnson & Johnson Sante' Beaute', France( (276417800)