NEUTROGENA OIL-FREE MOISTURE SUNSCREEN BROAD SPECTRUM SPF 35- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Neutrogena Oil-Free Moisture by

Drug Labeling and Warnings

Neutrogena Oil-Free Moisture 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 3%, Homosalate 12%, Octisalate 5%, Octocrylene 2.35%, Oxybenzone 6%

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, Dimethicone, Diethylhexyl 2,6-Naphthalate, Glycerin, Trisiloxane, PEG-100 Stearate, Glyceryl Stearate, Cetearyl Alcohol, Behenyl Alcohol, Caprylyl Methicone, Potassium Cetyl Phosphate, Styrene/Acrylates Copolymer, Hydrogenated Palm Glycerides, Benzyl Alcohol, Ethylhexylglycerin, Methylparaben, Cetearyl Glucoside, Xanthan Gum, Propylparaben, Disodium EDTA, BHT, Methylisothiazolinone

Questions or comments?

Visit www.neutrogena.com or call toll-free 800-582-4048 or 215-273-8755 (collect)

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

PRINCIPAL DISPLAY PANEL - 73 mL Bottle Carton

oil-free
moisture

with
sunscreen

BROAD SPECTRUM
SPF 35

facial moisturizer
with UVA/UVB protection

non-comedogenic
(won't clog pores)
Neutrogena®

DERMATOLOGIST RECOMMENDED

2.5 FL OZ (73mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA OIL-FREE MOISTURE   SUNSCREEN BROAD SPECTRUM SPF 35
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0342
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	23.5 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Dimethicone (UNII: 92RU3N3Y1O)
Trisiloxane (UNII: 9G1ZW13R0G)
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
Glycerin (UNII: PDC6A3C0OX)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
DOCOSANOL (UNII: 9G1OE216XY)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
Ethylhexylglycerin (UNII: 147D247K3P)
Benzyl Alcohol (UNII: LKG8494WBH)
Methylparaben (UNII: A2I8C7HI9T)
Cetearyl Glucoside (UNII: 09FUA47KNA)
Xanthan Gum (UNII: TTV12P4NEE)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
Methylisothiazolinone (UNII: 229D0E1QFA)
Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0342-2	1 in 1 CARTON	06/01/2010
1		73 mL in 1 BOTTLE, PUMP; 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	06/01/2010

Labeler - Johnson & Johnson Consumer Inc. (002347102)