Lubriderm® Daily Moisture LOTION Sunscreen BROAD SPECTRUM SPF 15

Drug Labeling and Warnings

Drug Details [pdf]

LUBRIDERM DAILY MOISTURE  SUNSCREEN BROAD SPECTRUM SPF15- avobenzone, octisalate, octocrylene, and oxybenzone lotion 
Johnson & Johnson Consumer Inc.

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.

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Lubriderm® Daily Moisture LOTION Sunscreen BROAD SPECTRUM SPF 15

Drug Facts

Active ingredients

Avobenzone (2%), Octisalate (4%), Octocrylene (3%), Oxybenzone (2.2%)

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

For sunscreen use:

  • apply liberally 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. – 2p.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, Glycerin, C12-15 Alkyl Benzoate, Cetyl Alcohol, Glyceryl Stearate, Cetearyl Alcohol, Stearic Acid, Phenoxyethanol, Ceteareth-20, Triethanolamine, Disodium EDTA, Fragrance, Panthenol, Tocopheryl Acetate, Xanthan Gum, Carbomer, Benzalkonium Chloride, Acrylates/C10-30 Alkyl Acrylate Crosspolymer ,Methylisothiazolinone

Questions?

Call toll-free 877-543-8477 or 215-273-8755 (collect) or visit www.lubriderm.com

Distributed in the US by:
JOHNSON & JOHNSON
CONSUMER PRODUCTS
COMPANY
Division of
Johnson & Johnson
Consumer Companies, Inc.
Skillman, NJ 08558-9418

PRINCIPAL DISPLAY PANEL - 400 mL Bottle Label

Lubriderm®
dermatologist developed

Daily
Moisture
LOTION

with
Sunscreen
BROAD SPECTRUM SPF 15

24® CLINICALLY SHOWN TO
MOISTURIZE FOR 24 HOURS

CLEAN, NON-GREASY FEEL

13.5 Fl. Oz. (400 mL)

PRINCIPAL DISPLAY PANEL - 400 mL Bottle Label
LUBRIDERM DAILY MOISTURE   SUNSCREEN BROAD SPECTRUM SPF15
avobenzone, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 58232-0753
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone20 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate40 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene30 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone22 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Glycerin (UNII: PDC6A3C0OX)  
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)  
Cetyl Alcohol (UNII: 936JST6JCN)  
Glyceryl Monostearate (UNII: 230OU9XXE4)  
Cetostearyl Alcohol (UNII: 2DMT128M1S)  
Phenoxyethanol (UNII: HIE492ZZ3T)  
Polyoxyl 20 Cetostearyl Ether (UNII: YRC528SWUY)  
Stearic Acid (UNII: 4ELV7Z65AP)  
Trolamine (UNII: 9O3K93S3TK)  
Edetate Disodium (UNII: 7FLD91C86K)  
Xanthan Gum (UNII: TTV12P4NEE)  
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)  
Panthenol (UNII: WV9CM0O67Z)  
Benzalkonium Chloride (UNII: F5UM2KM3W7)  
Methylisothiazolinone (UNII: 229D0E1QFA)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 58232-0753-1400 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product07/01/201008/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35207/01/201008/01/2019
Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 1/2019
Document Id: fc2d9e39-b4e1-4ff0-a3b5-2c35ff07d8f2
Set id: e4fbc1ac-f0ed-424b-b3e8-94a669b06cc1
Version: 4
Effective Time: 20190129