NEUTROGENA COOLDRY SPORT WITH MICROMESH SUNSCREEN BROAD SPECTRUM SPF70- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Neutrogena CoolDry Sport with Micromesh by

Drug Labeling and Warnings

Neutrogena CoolDry Sport with Micromesh 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, Sodium Polyacrylate, Silica, Tocopheryl Acetate, Ethylhexylglycerin, Decylene Glycol, Acrylates/Dimethicone Copolymer, Glyceryl Behenate, Glyceryl Dibehenate, Tribehenin, Phenoxyethanol, Chlorphenesin, Fragrance

Questions?

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

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

PRINCIPAL DISPLAY PANEL - 147 mL Bottle Label

NEW
Neutrogena®

COOLDRY
SPORT
WITH MICROMESH™

SUNSCREEN LOTION

Broad Spectrum SPF70
70

helioplex®
broad spectrum uvauvb

sweat evaporates away
for a cool, clean feel

water-resistant (80 minuts)

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

5.0 FL. OZ. (147 mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA COOLDRY SPORT WITH MICROMESH   SUNSCREEN BROAD SPECTRUM SPF70
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-448
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)
Dimethicone (UNII: 92RU3N3Y1O)
PEG-30 DIPOLYHYDROXYSTEARATE (4000 MW) (UNII: 9713Q0S7FO)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Ethylhexylglycerin (UNII: 147D247K3P)
Decylene Glycol (UNII: S57M60MI88)
Glyceryl Dibehenate (UNII: R8WTH25YS2)
Tribehenin (UNII: 8OC9U7TQZ0)
Phenoxyethanol (UNII: HIE492ZZ3T)
Chlorphenesin (UNII: I670DAL4SZ)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-448-01	147 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2014
2	NDC: 10812-448-02	29 mL in 1 BOTTLE; Type 0: Not a Combination Product	09/01/2015
3	NDC: 10812-448-04	14 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/01/2014

Labeler - Johnson & Johnson Consumer Inc. (002347102)