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

Neutrogena Healthy Skin Face by

Drug Labeling and Warnings

Neutrogena Healthy Skin Face 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 atleast 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, glycolic acid, dicaprylyl maleate, C12-15 alkyl benzoate, stearic acid, glycerin, cetyl alcohol, PEG-100 stearate, glyceryl stearate, sodium hydroxide, phenoxyethanol, sclerotium gum, tocopheryl acetate, caprylyl glycol, fragrance, xanthan gum, methylparaben, panthenol, bisabolol, propylparaben, tetrasodium EDTA, ascorbic acid

Questions?

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 73 mL Bottle Carton

NEUTROGENA®

Healthy Skin®
face lotion

with
sunscreen

Broad Spectrum
SPF 15

Renewing Moisturizer with
Multi-Vitamins and Alpha-Hydroxy

Clinically proven to:

• Soften and smooth rough,
  uneven skin
• Improve skin radiance and clarity

Neutrogena®

DERMATOLOGIST
RECOMMENDED

2.5 FL. OZ. (73mL)

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0299
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 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	30 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycolic Acid (UNII: 0WT12SX38S)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
DIOCTYL MALEATE (UNII: OD88G8439L)
Cetyl Alcohol (UNII: 936JST6JCN)
Glycerin (UNII: PDC6A3C0OX)
Stearic Acid (UNII: 4ELV7Z65AP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PEG-100 STEARATE (UNII: YD01N1999R)
Sodium Hydroxide (UNII: 55X04QC32I)
Phenoxyethanol (UNII: HIE492ZZ3T)
BETASIZOFIRAN (UNII: 2X51AD1X3T)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Caprylyl Glycol (UNII: 00YIU5438U)
Xanthan Gum (UNII: TTV12P4NEE)
METHYLPARABEN (UNII: A2I8C7HI9T)
Panthenol (UNII: WV9CM0O67Z)
LEVOMENOL (UNII: 24WE03BX2T)
Propylparaben (UNII: Z8IX2SC1OH)
EDETATE SODIUM (UNII: MP1J8420LU)
Ascorbic Acid (UNII: PQ6CK8PD0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0299-2	1 in 1 CARTON	04/01/2014
1		73 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
OTC MONOGRAPH NOT FINAL	part352	04/01/2014

Labeler - Johnson & Johnson Consumer Inc. (002347102)