| NDC | 53738-0712-0 |
| Set ID | 6f6ad58d-fab9-4c0b-8bee-0b8b38220d5d |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Johnson & Johnson Sante Beaute- France |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
-
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
- 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 Ingredients
Water, C12-15 Alkyl Benzoate, Glycerin, Cyclohexasiloxane, Silica, Tetrahydroxypropyl Ethylenediamine, Cetearyl Alcohol, Diethylhexyl 2,6-Naphthalate, Cyclopentasiloxane, Aluminum Starch Octenylsuccinate, Dimethicone, Phenoxyethanol, Steareth-2, Steareth-21, Citric Acid, Polyacrylamide, Cetearyl Glucoside, Fragrance, Methylparaben, Dimethicone/Vinyl Dimethicone Crosspolymer, Arachidyl Alcohol, C13-14 Isoparaffin, Disodium EDTA, Behenyl Alcohol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Propylparaben, Arachidyl Glucoside, Laureth-7, Ethylparaben, Benzalkonium Chloride
- Questions?
- PRINCIPAL DISPLAY PANEL - 38 mL Tube Carton
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INGREDIENTS AND APPEARANCE
ROC MULTI CORREXION LIFT ANTI GRAVITY DAY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF30
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53738-0712 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 120 mg in 1 mL Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 50 mg in 1 mL Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 17 mg in 1 mL Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 30 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Glycerin (UNII: PDC6A3C0OX) Cyclomethicone 6 (UNII: XHK3U310BA) Silicon Dioxide (UNII: ETJ7Z6XBU4) Edetol (UNII: Q4R969U9FR) Cetostearyl Alcohol (UNII: 2DMT128M1S) Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM) Cyclomethicone 5 (UNII: 0THT5PCI0R) Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294) Dimethicone (UNII: 92RU3N3Y1O) Phenoxyethanol (UNII: HIE492ZZ3T) Steareth-2 (UNII: V56DFE46J5) Steareth-21 (UNII: 53J3F32P58) Citric Acid Monohydrate (UNII: 2968PHW8QP) Cetearyl Glucoside (UNII: 09FUA47KNA) Methylparaben (UNII: A2I8C7HI9T) Arachidyl Alcohol (UNII: 1QR1QRA9BU) C13-14 Isoparaffin (UNII: E4F12ROE70) Edetate Disodium (UNII: 7FLD91C86K) Docosanol (UNII: 9G1OE216XY) Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate) (UNII: 255PIF62MS) Propylparaben (UNII: Z8IX2SC1OH) Arachidyl Glucoside (UNII: 6JVW35JOOJ) Laureth-7 (UNII: Z95S6G8201) Ethylparaben (UNII: 14255EXE39) Benzalkonium Chloride (UNII: F5UM2KM3W7) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53738-0712-0 1 in 1 CARTON 06/07/2012 12/01/2023 1 38 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 06/07/2012 12/01/2023 Labeler - Johnson & Johnson Sante Beaute- France (276417800)
