NEUTROGENA COOLDRY SPORT WITH MICROMESH SUNSCREEN BROAD SPECTRUM SPF50 PLUS- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone stick

Neutrogena CoolDry Sport with Micromesh Sunscreen Broad Spectrum SPF50 Plus by

Drug Labeling and Warnings

Neutrogena CoolDry Sport with Micromesh Sunscreen Broad Spectrum SPF50 Plus 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 10%
Oxybenzone 3%

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 and evenly 15 minutes before sun exposure
• ensure complete coverage to the area above the lip, nose, and tops of ears.
• 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
• after use, twist stick down prior to capping to ensure complete closure

INACTIVE INGREDIENT

Octyldodecyl Neopentanoate, Neopentyl Glycol Diethylhexanoate, Polyethylene, Paraffin, Ozokerite, Beeswax, C12-15 Alkyl Benzoate, Adipic Acid/Diglycol Crosspolymer, Neopentyl Glycol Diisostearate, Dimethicone, Diethylhexyl 2,6-Naphthalate, BHT, Fragrance

Questions?

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

PRINCIPAL DISPLAY PANEL - 42 g Canister Label

Neutrogena®

NEW
COOLDRY
SPORT
WITH MICROMESH™

SUNSCREEN STICK
Broad Spectrum SPF50+
50+
helioplex®
broad spectrum uvauvb

water-resistant (80 minutes)

NET WT. 1.5 OZ. (42g)

INGREDIENTS AND APPEARANCE

NEUTROGENA COOLDRY SPORT WITH MICROMESH SUNSCREEN BROAD SPECTRUM SPF50 PLUS 
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-460
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 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	150 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	100 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Neopentyl Glycol Diethylhexanoate (UNII: U68ZV6W62C)
High Density Polyethylene (UNII: UG00KM4WR7)
Paraffin (UNII: I9O0E3H2ZE)
Ceresin (UNII: Q1LS2UJO3A)
Yellow Wax (UNII: 2ZA36H0S2V)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)
Dimethicone (UNII: 92RU3N3Y1O)
Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-460-01	42 g in 1 CANISTER; Type 0: Not a Combination Product	08/01/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	08/01/2015

Labeler - Johnson & Johnson Consumer Inc. (002347102)