NEUTROGENA OIL FREE MOISTURE BROAD SPECTRUM SPF15- avobenzone, octisalate, octocrylene, and oxybenzone lotion

Neutrogena Oil Free Moisture Broad Spectrum SPF15 by

Drug Labeling and Warnings

Neutrogena Oil Free Moisture Broad Spectrum SPF15 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 INGREDIENT

Active ingredients	Purpose
Avobenzone (1.5%)	Sunscreen
Octisalate (5%)	Sunscreen
Octocrylene (3%)	Sunscreen
Oxybenzone (4%)	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, Octyldodecyl Neopentanoate, Glycerin, Emulsifying Wax NF, Glyceryl Stearate, PEG-100 Stearate, Dimethicone, Phenoxyethanol, Ethylhexylglycerin, Caprylyl Glycol, Carbomer, Triethanolamine, Methylparaben, Disodium EDTA, Ethylene Brassylate, Dipropylene Glycol, Dimethyl Heptenal

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 - 118 mL Bottle Carton

oil-free
moisture

with
sunscreen

Broad Spectrum
SPF15

facial moisturizer
with sun protection

non-comedogenic
(doesn't clog pores)

Neutrogena®

DERMATOLOGIST RECOMMENDED

4 FL. OZ. (118mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA OIL FREE MOISTURE BROAD SPECTRUM SPF15 
avobenzone, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-979
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)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Glycerin (UNII: PDC6A3C0OX)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Dimethicone (UNII: 92RU3N3Y1O)
Phenoxyethanol (UNII: HIE492ZZ3T)
Ethylhexylglycerin (UNII: 147D247K3P)
Caprylyl Glycol (UNII: 00YIU5438U)
Trolamine (UNII: 9O3K93S3TK)
Methylparaben (UNII: A2I8C7HI9T)
Edetate Disodium (UNII: 7FLD91C86K)
Ethylene Brassylate (UNII: 9A87HC7ROD)
Dipropylene Glycol (UNII: E107L85C40)
2,6-Dimethyl-5-Heptenal (UNII: Z331YX9EL9)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-979-01	1 in 1 CARTON	09/15/2014
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product
2	NDC: 10812-979-02	14 mL in 1 TUBE; Type 0: Not a Combination Product	09/15/2014
3	NDC: 10812-979-03	50 mL in 1 TUBE; Type 0: Not a Combination Product	05/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/15/2014

Labeler - Johnson & Johnson Consumer Inc. (002347102)