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 value of SPF 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, 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

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

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

oil-free
moisture

with
sunscreen

BROAD SPECTRUM
SPF 15

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: 69968-0616
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)
CARBOXYPOLYMETHYLENE (UNII: 0A5MM307FC)
Trolamine (UNII: 9O3K93S3TK)
Methylparaben (UNII: A2I8C7HI9T)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Ethylene Brassylate (UNII: 9A87HC7ROD)
Dipropylene Glycol (UNII: E107L85C40)
2,6-Dimethyl-5-Heptenal (UNII: Z331YX9EL9)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0616-4	1 in 1 CARTON	06/21/2019
1		118 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	06/21/2019

Labeler - Johnson & Johnson Consumer Inc. (002347102)