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NDC 53738-0712-00 RoC Multi correxion Lift Anti Gravity Day Moisturizer 30; 120; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL Details

RoC Multi correxion Lift Anti Gravity Day Moisturizer 30; 120; 50; 17; 30 mg/mL; mg/mL; mg/mL; mg/mL; mg/mL

RoC Multi correxion Lift Anti Gravity Day Moisturizer is a TOPICAL LOTION in the HUMAN OTC DRUG category. It is labeled and distributed by Johnson & Johnson Sante Beaute- France. The primary component is AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE.

Product Information

NDC	53738-0712
Product ID	53738-0712_163e5b78-6a0e-4ec6-b696-f742f70820ee
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	RoC Multi correxion Lift Anti Gravity Day Moisturizer
Proprietary Name Suffix	Sunscreen Broad Spectrum SPF30
Non-Proprietary Name	Avobenzone, Homosalate, Octisalate, Octocrylene, and Oxybenzone
Product Type	HUMAN OTC DRUG
Dosage Form	LOTION
Route	TOPICAL
Active Ingredient Strength	30; 120; 50; 17; 30
Active Ingredient Units	mg/mL; mg/mL; mg/mL; mg/mL; mg/mL
Substance Name	AVOBENZONE; HOMOSALATE; OCTISALATE; OCTOCRYLENE; OXYBENZONE
Labeler Name	Johnson & Johnson Sante Beaute- France
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	n/a

Package

Package Images

NDC 53738-0712-00 (53738071200)

Pricing Information	N/A
NDC Package Code	53738-0712-0
Billing NDC	53738071200
Package	1 TUBE in 1 CARTON (53738-0712-0) / 38 mL in 1 TUBE
Marketing Start Date	2012-06-07
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 6f6ad58d-fab9-4c0b-8bee-0b8b38220d5d Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

Avobenzone (3%), Homosalate (12%), Octisalate (5%), Octocrylene (1.7%), Oxybenzone (3%)

Purpose

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

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

protect this product from excessive heat and direct sun
may stain some fabrics

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?

1-800-RoC-1964 (1-800-762-1964); Outside US, dial collect 215-273-8755 or visit www.rocskincare.com

PRINCIPAL DISPLAY PANEL - 38 mL Tube Carton

RoC®

WE KEEP OUR PROMISES®

MULTI CORREXION®

LIFT

ANTI-GRAVITY

DAY MOISTURIZER

WITH

SUNSCREEN

BROAD SPECTRUM SPF 30

Anti-Wrinkle – Lifts – Protects

PROTIENT™ PLUS™ Firming Technology

1.3 fl oz (38 mL)

Principal Display Panel - 38 mL Tube Carton

INGREDIENTS AND APPEARANCE

ROC MULTI CORREXION LIFT ANTI GRAVITY DAY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF30

avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:53738-0712
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH NOT FINAL	part352	06/07/2012	12/01/2023

Labeler - Johnson & Johnson Sante Beaute- France (276417800)

Revised: 1/2019

Document Id: 163e5b78-6a0e-4ec6-b696-f742f70820ee

Set id: 6f6ad58d-fab9-4c0b-8bee-0b8b38220d5d

Version: 3

Effective Time: 20190111