NEUTROGENA HEALTHY SKIN ANTI-WRINKLE SYSTEM- avobenzone, octisalate, octocrylene, and oxybenzone kit

Neutrogena Healthy Skin Anti-Wrinkle System by

Drug Labeling and Warnings

Neutrogena Healthy Skin Anti-Wrinkle System 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 1.5%
Octisalate 5%
Octocrylene 3%
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 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, glycerin, C12-15 alkylbenzoate, cetearyl alcohol, glyceryl stearate, cetyl alcohol, dimethicone, PEG-75 stearate, tocopheryl acetate, phenoxyethanol, panthenol, caprylyl glycol, carbomer, cetearyl glucoside, butylene glycol, methylparaben, ceteth-20, steareth-20, camellia oleifera leaf extract, propylparaben, chlorphenesin, BHT, disodium EDTA, sodium hydroxide, tocopherol, retinol, polysorbate 20

Questions or Comments?

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

PRINCIPAL DISPLAY PANEL - Kit Carton

NEUTROGENA®

Healthy Skin®

Anti-Wrinkle

System

• With Retinol, to visibly
  reduce the look of
  fine lines and wrinkles
• #1 dermatologist
  recommended
  anti-aging brand

Neutrogena®

DERMATOLOGIST RECOMMENDED

Fresh Foaming Cleanser 6.7 FL. OZ. (198 mL), Healthy Skin Eye Cream NET WT. 0.5 OZ. (15 g),
Healthy Skin Anti-Wrinkle Cream with Sunscreen Broad Spectrum SPF 15 NET WT. 1.4 OZ. (40 g)

INGREDIENTS AND APPEARANCE

NEUTROGENA HEALTHY SKIN ANTI-WRINKLE SYSTEM 
avobenzone, octisalate, octocrylene, and oxybenzone kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0103

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0103-9	1 in 1 CARTON	09/16/2015	12/01/2023

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	40 g
Part 2	1 BOTTLE	200 mL
Part 3	1 TUBE	15 g

Part 1 of 3

NEUTROGENA HEALTHY SKIN ANTI-WRINKLE WITH SUNSCREEN   BROAD SPECTRUM SPF15
avobenzone, octisalate, octocrylene, and oxybenzone cream

Product Information
Item Code (Source)	NDC: 69968-0170
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	15 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	30 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Dimethicone (UNII: 92RU3N3Y1O)
Cetyl Alcohol (UNII: 936JST6JCN)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-75 Stearate (UNII: OT38R0N74H)
Panthenol (UNII: WV9CM0O67Z)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Phenoxyethanol (UNII: HIE492ZZ3T)
Caprylyl Glycol (UNII: 00YIU5438U)
Carboxypolymethylene (UNII: 0A5MM307FC)
Cetearyl Glucoside (UNII: 09FUA47KNA)
Butylene Glycol (UNII: 3XUS85K0RA)
Ceteth-20 (UNII: I835H2IHHX)
Steareth-20 (UNII: L0Q8IK9E08)
Methylparaben (UNII: A2I8C7HI9T)
Camellia Oleifera Leaf (UNII: 5077EL0C60)
Chlorphenesin (UNII: I670DAL4SZ)
Propylparaben (UNII: Z8IX2SC1OH)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Edetate Disodium (UNII: 7FLD91C86K)
Sodium Hydroxide (UNII: 55X04QC32I)
Tocopherol (UNII: R0ZB2556P8)
Polysorbate 20 (UNII: 7T1F30V5YH)
Retinol (UNII: G2SH0XKK91)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0170-1	40 g 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	05/10/2014	12/01/2023

Part 2 of 3

NEUTROGENA FRESH FOAMING CLEANSER 
cleansing (cold creams, cleansing lotions, liquids, and pads) solution

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Lauryl Glucoside (UNII: 76LN7P7UCU)
INGR	Decyl Glucoside (UNII: Z17H97EA6Y)
INGR	Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
INGR	Glycereth-7 (UNII: 3D2Y91QZ2H)
INGR	Sodium Cocoyl Sarcosinate (UNII: 1R9DUY89CZ)
INGR	Glycol Stearate (UNII: 0324G66D0E)
INGR	Coco Monoethanolamide (UNII: C80684146D)
INGR	PEG-120 Methyl Glucose Dioleate (UNII: YM0K64F20V)
INGR	Edetate Sodium (UNII: MP1J8420LU)
INGR	DMDM Hydantoin (UNII: BYR0546TOW)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		200 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		06/01/2010	12/01/2023

Part 3 of 3

NEUTROGENA HEALTHY SKIN EYE 
other skin care preparations cream

Product Information
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	Water (UNII: 059QF0KO0R)
INGR	Cetyl Alcohol (UNII: 936JST6JCN)
INGR	Glycerin (UNII: PDC6A3C0OX)
INGR	Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
INGR	Stearic Acid (UNII: 4ELV7Z65AP)
INGR	Glyceryl Monostearate (UNII: 230OU9XXE4)
INGR	PEG-100 Stearate (UNII: YD01N1999R)
INGR	Ethylhexyl Palmitate (UNII: 2865993309)
INGR	Melibiose (UNII: 9B1VBE526I)
INGR	Vitamin A Palmitate (UNII: 1D1K0N0VVC)
INGR	Glycolic Acid (UNII: 0WT12SX38S)
INGR	.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
INGR	Panthenol (UNII: WV9CM0O67Z)
INGR	Levomenol (UNII: 24WE03BX2T)
INGR	Dimethicone (UNII: 92RU3N3Y1O)
INGR	Mica (UNII: V8A1AW0880)
INGR	Silicon Dioxide (UNII: ETJ7Z6XBU4)
INGR	Edetate Sodium (UNII: MP1J8420LU)
INGR	Xanthan Gum (UNII: TTV12P4NEE)
INGR	Methylparaben (UNII: A2I8C7HI9T)
INGR	Propylparaben (UNII: Z8IX2SC1OH)
INGR	Diazolidinyl Urea (UNII: H5RIZ3MPW4)
INGR	Sodium Glycolate (UNII: B75E535IMI)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		15 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
COSMETIC		06/01/2010	12/01/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/16/2015	12/01/2023

Labeler - Johnson & Johnson Consumer Inc. (002347102)