NEUTROGENA COOLDRY SPORT WITH MICROMESH SUNSCREEN BROAD SPECTRUM SPF 50- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Neutrogena CoolDry Sport with Micromesh Sunscreen Broad Spectrum SPF 50 by

Drug Labeling and Warnings

Neutrogena CoolDry Sport with Micromesh Sunscreen Broad Spectrum SPF 50 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 ingredient	Purpose
Avobenzone 2.7%	Sunscreen
Homosalate 9%	Sunscreen
Octisalate 4.5%	Sunscreen
Octocrylene 8%	Sunscreen
Oxybenzone 4.5%	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: Ask a doctor

Other information

• protect this product from excessive heat and direct sun
• may stain some fabrics

Inactive ingredients

water, dimethicone, PEG-30 dipolyhydroxystearate, glyceryl behenate, cetyl PEG/PPG-10/1 dimethicone, sodium polyacrylate, silica, phenoxyethanol, ethylhexylglycerin, chlorphenesin, decylene glycol, tocopheryl acetate, acrylates/ dimethicone copolymer, fragrance

Questions?

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

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

PRINCIPAL DISPLAY PANEL - 147 mL Bottle Label

Neutrogena®
COOLDRY

SPORT

WITH MICROMESH®
SUNSCREEN LOTION
Broad Spectrum SPF 50

50

helioplex®
broad spectrum uva uvb
sweat evaporates away
for a cool, clean feel
water-resistant (80 minutes)

#1 DERMATOLOGIST
RECOMMENDED SUNCARE
5.0 FL. OZ. (147 mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA COOLDRY SPORT WITH MICROMESH SUNSCREEN BROAD SPECTRUM SPF 50 
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0402
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	27 mg  in 1 mL
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	90 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	45 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	80 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	45 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Dimethicone (UNII: 92RU3N3Y1O)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
GLYCERYL DIBEHENATE (UNII: R8WTH25YS2)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
phenoxyethanol (UNII: HIE492ZZ3T)
ethylhexylglycerin (UNII: 147D247K3P)
chlorphenesin (UNII: I670DAL4SZ)
decylene glycol (UNII: S57M60MI88)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0402-5	147 mL in 1 BOTTLE; 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)