NEUTROGENA ULTRA SHEER DRY TOUCH SUNSCREEN BROAD SPECTRUM SPF45- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Neutrogena Ultra Sheer Dry Touch by

Drug Labeling and Warnings

Neutrogena Ultra Sheer Dry Touch 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 10%
Octisalate 5%
Octocrylene 2.8%
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, butyloctyl salicylate, styrene/acrylates copolymer, silica, diethylhexyl 2,6-naphthalate, VP/hexadecene copolymer, dimethicone, caprylyl methicone, phenoxyethanol, ethylhexylglycerin, glyceryl stearate, PEG-100 stearate, trimethylsiloxysilicate, sodium polyacrylate, methylparaben, behenyl alcohol, xanthan gum, propylparaben, ethylparaben, fragrance, disodium EDTA, BHT, iodopropynyl butylcarbamate

Questions?

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

SPL UNCLASSIFIED SECTION

Dist. by Neutrogena Corp., Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 88 mL Tube Label

Neutrogena®

Ultra Sheer®
DRY-TOUCH

SUNSCREEN

Broad Spectrum SPF 45
45

helioplex®
broad spectrum uvauvb

LIGHTWEIGHT
CLEAN FEEL

fast absorbing
water resistant (80 minutes)

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

3.0 FL OZ (88mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA ULTRA SHEER DRY TOUCH   SUNSCREEN BROAD SPECTRUM SPF45
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-535
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	100 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	28 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Docosanol (UNII: 9G1OE216XY)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
butyloctyl Salicylate (UNII: 2EH13UN8D3)
Caprylyl Trisiloxane (UNII: Q95M2P1KJL)
Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)
Dimethicone (UNII: 92RU3N3Y1O)
Edetate Disodium (UNII: 7FLD91C86K)
Ethylhexylglycerin (UNII: 147D247K3P)
Ethylparaben (UNII: 14255EXE39)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)
Methylparaben (UNII: A2I8C7HI9T)
PEG-100 Stearate (UNII: YD01N1999R)
Phenoxyethanol (UNII: HIE492ZZ3T)
Propylparaben (UNII: Z8IX2SC1OH)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
Water (UNII: 059QF0KO0R)
Xanthan Gum (UNII: TTV12P4NEE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-535-01	88 mL in 1 TUBE; Type 0: Not a Combination Product	09/01/2005
2	NDC: 10812-535-03	2 in 1 PACKAGE	09/01/2005
2		88 mL in 1 TUBE; 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	09/01/2005

Labeler - Johnson & Johnson Consumer Inc. (002347102)