NEUTROGENA HEALTHY DEFENSE SPF50- titanium dioxide and zinc oxide lotion

Neutrogena Healthy Defense SPF50 by

Drug Labeling and Warnings

Neutrogena Healthy Defense SPF50 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

Titanium Dioxide 5%, Zinc Oxide 3%

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 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

Inactive Ingredients

water, C12-15 alkyl benzoate, ethylhexyl isononanoate, styrene/acrylates copolymer, dimethicone, silica, ethylhexyl hydroxystearate, glycerin, glyceryl stearate, cetyl alcohol, PEG-100 stearate, ethylhexylglycerin, polyhydroxystearic acid, phenoxyethanol, alumina, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, PEG-75 stearate, pentylene glycol, bisabolol, caprylyl glycol, isohexadecane, chlorphenesin, aluminum stearate, disodium EDTA, PPG-12/SMDI copolymer, ceteth-20, steareth-20, dipropylene glycol dibenzoate, triethoxycaprylylsilane, polysorbate 60, PPG-15 stearyl ether benzoate, BHT

Questions?

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

SPL UNCLASSIFIED SECTION

Dist. by Neutrogena Corp.
Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 50mL Tube Carton

HEALTHY
DEFENSE®

daily
moisturizer
with
sunscreen

Broad Spectrum
SPF 50

pureSCREEN®
100% naturally-sourced sunscreens

SENSITIVE SKIN
Lightweight, non-greasy, fragrance free

Neutrogena®

#1 DERMATOLOGIST RECOMMENDED
FACIAL MOISTURE

1.7 FL OZ (50mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA HEALTHY DEFENSE SPF50 
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-007
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	50 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Ethylhexyl Isononanoate (UNII: I6KB4GE3K4)
Dimethicone (UNII: 92RU3N3Y1O)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Ethylhexyl Hydroxystearate (UNII: B7I80BVV5E)
Glycerin (UNII: PDC6A3C0OX)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Cetyl Alcohol (UNII: 936JST6JCN)
PEG-100 Stearate (UNII: YD01N1999R)
Ethylhexylglycerin (UNII: 147D247K3P)
Phenoxyethanol (UNII: HIE492ZZ3T)
Aluminum Oxide (UNII: LMI26O6933)
PEG-75 Stearate (UNII: OT38R0N74H)
Pentylene Glycol (UNII: 50C1307PZG)
Levomenol (UNII: 24WE03BX2T)
Caprylyl Glycol (UNII: 00YIU5438U)
Isohexadecane (UNII: 918X1OUF1E)
Chlorphenesin (UNII: I670DAL4SZ)
Aluminum Stearate (UNII: U6XF9NP8HM)
Edetate Disodium (UNII: 7FLD91C86K)
Ceteth-20 (UNII: I835H2IHHX)
Steareth-20 (UNII: L0Q8IK9E08)
Dipropylene Glycol Dibenzoate (UNII: 6OA5ZDY41O)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Polysorbate 60 (UNII: CAL22UVI4M)
PPG-15 Stearyl Ether Benzoate (UNII: 80D2J6361M)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-007-01	1 in 1 CARTON	06/25/2013	05/25/2014
1		50 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	06/25/2013	05/25/2014

Labeler - Johnson & Johnson Consumer Inc. (002347102)