NEUTROGENA HEALTHY DEFENSE DAILY MOISTURIZER SUNSCREEN BROAD SPECTRUM SPF50- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Neutrogena Healthy Defense Daily Moisturizer by

Drug Labeling and Warnings

Neutrogena Healthy Defense Daily Moisturizer 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 generously 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 value of SPF 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

Inactive ingredients

Water, Dimethicone, Trisiloxane, Diethylhexyl 2,6-Naphthalate, Glycerin , Glyceryl Stearate, PEG-100 Stearate, Cetearyl Alcohol, Potassium Cetyl Phosphate, Behenyl Alcohol, Caprylyl Methicone, Ethylhexylglycerin, Pantothenic Acid, Retinyl Palmitate, Ascorbic Acid, Tocopheryl Acetate, Tocopherol, BHT, Polymethyl Methacrylate, Hydrogenated Palm Glycerides, Styrene/Acrylates Copolymer, Cetearyl Glucoside, Xanthan Gum, Disodium EDTA, Methylparaben, Propylparaben, Methylisothiazolinone, Benzyl Alcohol

Questions or comments?

Visit www.neutrogena.com or call toll-free 800-299-4786 or 215-273-8755 (collect)

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Dist. by Neutrogena Corp.
Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton

HEALTHY
DEFENSE®

daily
moisturizer
with
sunscreen

Broad Spectrum
SPF 50

helioplex®
broad spectrum uvauvb

Lightweight, non-greasy moisturizer

Neutrogena®

#1 DERMATOLOGIST RECOMMENDED
FACIAL MOISTURIZER

1.7 FL OZ (50mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA HEALTHY DEFENSE DAILY MOISTURIZER   SUNSCREEN BROAD SPECTRUM SPF50
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-534
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)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Docosanol (UNII: 9G1OE216XY)
Caprylyl Trisiloxane (UNII: Q95M2P1KJL)
Ethylhexylglycerin (UNII: 147D247K3P)
Pantothenic Acid (UNII: 19F5HK2737)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Ascorbic Acid (UNII: PQ6CK8PD0R)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Tocopherol (UNII: R0ZB2556P8)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
Hydrogenated Palm Glycerides (UNII: YCZ8EM144Q)
Cetearyl Glucoside (UNII: 09FUA47KNA)
Xanthan Gum (UNII: TTV12P4NEE)
Edetate Disodium (UNII: 7FLD91C86K)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
Methylisothiazolinone (UNII: 229D0E1QFA)
Benzyl Alcohol (UNII: LKG8494WBH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-534-10	1 in 1 CARTON	09/24/2012
1		50 mL in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 10812-534-01	12 in 1 CARTON	09/24/2012
2		14 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	09/24/2012

Labeler - Johnson & Johnson Consumer Inc. (002347102)