NEUTROGENA COOLDRY SPORT WITH MICROMESH FACE OIL FREE SUNSCREEN BROAD SPECTRUM SPF 70- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Neutrogena CoolDry Sport with Micromesh Face Oil free by

Drug Labeling and Warnings

Neutrogena CoolDry Sport with Micromesh Face Oil free 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 15%, Octisalate 5%
Octocrylene 4%, Oxybenzone 6%

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

• apply liberally 15 minutes before sun exposure
• reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
• 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, dimethicone, cetyl PEG/PPG-10/1 dimethicone, PEG-30 dipolyhydroxystearate, glyceryl behenate, sodium polyacrylate, silica, ethylhexylglycerin, decylene gycol, tocopheryl acetate, acrylates/dimethicone copolymer, chlorphenesin, phenoxyethanol

Questions?

Call toll-free 800-299-4786 or 215-273-8755 (collect) or visit www.neutrogena.com

SPL UNCLASSIFIED SECTION

Dist. by Neutrogena Corp.,
L.A., CA 90045

PRINCIPAL DISPLAY PANEL - 88 mL Tube Label

NEW
Neutrogena®

COOLDRY
SPORT
WITH MICROMESH™
FACE
OIL-FREE SUNSCREEN LOTION

Broad Spectrum SPF 70

70

helioplex®
broad spectrum uvauvb

sweat evaporates away
for a cool, clean feel

water-resistant (80 minutes)

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

3.0 FL. OZ. (88mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA COOLDRY SPORT WITH MICROMESH FACE OIL FREE   SUNSCREEN BROAD SPECTRUM SPF 70
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-901
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	150 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	40 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
PEG-30 dipolyhydroxystearate (UNII: 9713Q0S7FO)
Dimethicone (UNII: 92RU3N3Y1O)
Glyceryl Dibehenate (UNII: R8WTH25YS2)
Ethylhexylglycerin (UNII: 147D247K3P)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
decylene glycol (UNII: S57M60MI88)
phenoxyethanol (UNII: HIE492ZZ3T)
chlorphenesin (UNII: I670DAL4SZ)
.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-901-03	88 mL in 1 TUBE; Type 0: Not a Combination Product	10/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	10/01/2015

Labeler - Johnson & Johnson Consumer Inc. (002347102)