LUBRIDERM DAILY MOISTURE WITH SUNSCREEN BROAD SPECTRUM SPF15- avobenzone, octisalate, octocrylene, oxybenzone lotion

Lubriderm Daily Moisture with by

Drug Labeling and Warnings

Lubriderm Daily Moisture with by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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. - 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, 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

SPL UNCLASSIFIED SECTION

Distributed by:
JOHNSON & JOHNSON
CONSUMER INC.
Skillman, NJ 08558

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)

INGREDIENTS AND APPEARANCE

LUBRIDERM DAILY MOISTURE WITH   SUNSCREEN BROAD SPECTRUM SPF15
avobenzone, octisalate, octocrylene, oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0305
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	20 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	40 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	30 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	22 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 ANHYDROUS (UNII: 8NLQ36F6MM)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTHENOL (UNII: WV9CM0O67Z)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0305-3	400 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product	07/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/01/2010

Labeler - Johnson & Johnson Consumer Inc. (002347102)