NEUTROGENA ULTRA SHEER DRY TOUCH SUNSCREEN BROAD SPECTRUM SPF100 PLUS- 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 15%
Octisalate 5%
Octocrylene 10%
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, styrene/acrylates copolymer, silica, beeswax, cyclopentasiloxane, ethylhexylglycerin, glyceryl stearate, PEG-100 stearate, acrylates/dimethicone copolymer, acrylates/C10-30 alkyl acrylate crosspolymer, fragrance, chlorphenesin, triethanolamine, diethylhexyl 2,6-naphthalate, dipotassium glycyrrhizate, disodium EDTA, BHT, methylisothiazolinone

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 100+
100+

helioplex®
broad spectrum uva-uvb

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 SPF100 PLUS
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-366
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	100 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
Yellow Wax (UNII: 2ZA36H0S2V)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Chlorphenesin (UNII: I670DAL4SZ)
Cyclomethicone 5 (UNII: 0THT5PCI0R)
Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Edetate Disodium (UNII: 7FLD91C86K)
Ethylhexylglycerin (UNII: 147D247K3P)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Methylisothiazolinone (UNII: 229D0E1QFA)
PEG-100 Stearate (UNII: YD01N1999R)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Trolamine (UNII: 9O3K93S3TK)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-366-01	88 mL in 1 TUBE; Type 0: Not a Combination Product	04/01/2010	05/02/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	04/01/2010	05/02/2022

Labeler - Johnson & Johnson Consumer Inc. (002347102)