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

Neurogena Healthy Defense Moisturizer by

Drug Labeling and Warnings

Neurogena Healthy Defense 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 4%
Octisalate 5%
Octocrylene 5%
Oxybenzone 4%

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:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• 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, Glycerin , C12-15 Alkyl Benzoate, Cetyl Dimethicone, Silica, Styrene/Acrylates Copolymer, Steareth-100, Ethylhexylglycerin, Steareth-2, Dimethicone, Phenoxyethanol, Fragrance, Caprylyl Glycol, Disodium EDTA, Diethylhexyl 2,6-Naphthalate, Xanthan Gum, Mannan, BHT, Beta-Glucan, Pentylene Glycol , Chlorphenesin

Questions or comments?

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

SPL UNCLASSIFIED SECTION

Dist. by
Neutrogena Corporation
Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 40mL Bottle Carton

HEALTHY
DEFENSE®
Liquid
Moisturizer

With
Sunscreen

Broad Spectrum
SPF 50

helioplex®
broad specrum uvauvb

Daily ultralight fluid goes on invisibly

liquid
formula

Neutrogena®

#1 DERMATOLOGIST RECOMMENDED
FACIAL MOISTURE

1.4 FL OZ (40mL)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-425
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	40 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	50 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Steareth-100 (UNII: 4OH5W9UM87)
Ethylhexylglycerin (UNII: 147D247K3P)
Steareth-2 (UNII: V56DFE46J5)
Dimethicone (UNII: 92RU3N3Y1O)
Phenoxyethanol (UNII: HIE492ZZ3T)
Caprylyl Glycol (UNII: 00YIU5438U)
Edetate Disodium (UNII: 7FLD91C86K)
Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)
Xanthan Gum (UNII: TTV12P4NEE)
Yeast Mannan (UNII: 91R887N59P)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Pentylene Glycol (UNII: 50C1307PZG)
Chlorphenesin (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-425-01	1 in 1 CARTON	08/28/2012	12/01/2023
1		40 mL in 1 BOTTLE, PLASTIC; 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	08/28/2012	12/01/2023

Labeler - Johnson & Johnson Consumer Inc. (002347102)