NEUTROGENA HEALTHY SKIN FIRMING SUNSCREEN BROAD SPECTRUM SPF15- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Neutrogena Healthy Skin Firming by

Drug Labeling and Warnings

Neutrogena Healthy Skin Firming 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 5%
Oxybenzone 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 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, butylene glycol, silica, tetrahydroxypropyl ethylenediamine, C12-15 alkyl benzoate, cetearyl alcohol, dimethicone, benzyl alcohol, cyclopentasiloxane, steareth-2, glyceryl stearate, steareth-21, phenoxyethanol, citric acid, dimethicone/vinyl dimethicone crosspolymer, cetearyl glucoside, aluminum starch octenylsuccinate, polyacrylamide, fragrance, arachidyl alcohol, PEG-100 stearate, C13-14 isoparaffin, methylparaben, ethylparaben disodium EDTA, behenyl alcohol, acrylates/C10-30 alkyl acrylate crosspolymer, pentaerythrityl tetra-di-t-butyl hydroxyhydrocinnamate, propylparaben, arachidyl glucoside, laureth-7, polymethyl methacrylate, tocopheryl acetate, pantothenic acid, ascorbic acid, retinyl palmitate

Questions?

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 73 mL Bottle Carton

NEUTROGENA
Healthy Skin®
Firming cream

with
sunscreen

Broad Spectrum
SPF 15

firms & lifts

A Firming Moisturizer
with Multi-Vitamins and Tetrol-E®

• Visibly improves skin elasticity and
  firmness while reducing the look of
  wrinkles in just 4 weeks

Neutrogena®

DERMATOLOGIST
RECOMMENDED

2.5 FL OZ (73mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA HEALTHY SKIN FIRMING   SUNSCREEN BROAD SPECTRUM SPF15
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0132
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	50 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Butylene Glycol (UNII: 3XUS85K0RA)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Edetol (UNII: Q4R969U9FR)
silicon dioxide (UNII: ETJ7Z6XBU4)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Benzyl Alcohol (UNII: LKG8494WBH)
Dimethicone (UNII: 92RU3N3Y1O)
Steareth-2 (UNII: V56DFE46J5)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Steareth-21 (UNII: 53J3F32P58)
Phenoxyethanol (UNII: HIE492ZZ3T)
Citric Acid Monohydrate (UNII: 2968PHW8QP)
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)
Cetearyl Glucoside (UNII: 09FUA47KNA)
Arachidyl Alcohol (UNII: 1QR1QRA9BU)
PEG-100 Stearate (UNII: YD01N1999R)
C13-14 Isoparaffin (UNII: E4F12ROE70)
Edetate Disodium (UNII: 7FLD91C86K)
Methylparaben (UNII: A2I8C7HI9T)
Ethylparaben (UNII: 14255EXE39)
Docosanol (UNII: 9G1OE216XY)
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked) (UNII: 59TL3WG5CO)
Propylparaben (UNII: Z8IX2SC1OH)
Pentaerythritol Tetrakis(3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate) (UNII: 255PIF62MS)
Arachidyl Glucoside (UNII: 6JVW35JOOJ)
Laureth-7 (UNII: Z95S6G8201)
Poly(Methyl Methacrylate; 450000 MW) (UNII: Z47NNT4J11)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Pantothenic Acid (UNII: 19F5HK2737)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Ascorbic Acid (UNII: PQ6CK8PD0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0132-2	1 in 1 CARTON	10/02/2010
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	10/02/2010

Labeler - Johnson & Johnson Consumer Inc. (002347102)