NEUTROGENA ULTRA SHEER DRY TOUCH SUNSCREEN BROAD SPECTRUM SPF55- avobenzone, homosalate, octisalate, and octocrylene lotion

Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF55 by

Drug Labeling and Warnings

Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF55 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 ingredients	Purpose
Avobenzone 3%	Sunscreen
Homosalate 10%	Sunscreen
Octisalate 5%	Sunscreen
Octocrylene 10%	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, Dimethicone, Potassium Cetyl Phosphate, Benzyl Alcohol, Beeswax, Caprylyl Methicone, Glyceryl Stearate, PEG-100 Stearate, Cetyl Dimethicone, Caprylyl Glycol, Ethylhexylglycerin, Aluminum Starch Octenylsuccinate, Behenyl Alcohol, Acrylates/Dimethicone Copolymer, Xanthan Gum, Sodium Polyacrylate, Chlorphenesin, Dimethicone PEG - 10/15 Crosspolymer, Hydrolyzed Jojoba Esters, Fragrance, Disodium EDTA, Ethylhexyl Stearate, Tocopheryl Acetate, BHT, Trideceth-6, Jojoba Esters

Questions?

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

SPL UNCLASSIFIED SECTION

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

PRINCIPAL DISPLAY PANEL - 147 mL Tube Label

VALUE SIZE
Neutrogena®
#1 DERMATOLOGIST RECOMMENDED BRAND

Ultra Sheer®
dry-touch

sunscreen

BROAD SPECTRUM SPF 55
55

helioplex®
broad spectrum uvauvb

lightweight clean feel
oxybenzone free
water resistant (80 minutes)

5.0 FL OZ (147 mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA ULTRA SHEER DRY TOUCH SUNSCREEN BROAD SPECTRUM SPF55 
avobenzone, homosalate, octisalate, and octocrylene lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0576
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	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Dimethicone (UNII: 92RU3N3Y1O)
Potassium Cetyl Phosphate (UNII: 03KCY6P7UT)
Benzyl Alcohol (UNII: LKG8494WBH)
Yellow Wax (UNII: 2ZA36H0S2V)
Caprylyl Trisiloxane (UNII: Q95M2P1KJL)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Caprylyl Glycol (UNII: 00YIU5438U)
Ethylhexylglycerin (UNII: 147D247K3P)
Aluminum Starch Octenylsuccinate (UNII: I9PJ0O6294)
Docosanol (UNII: 9G1OE216XY)
Xanthan Gum (UNII: TTV12P4NEE)
Chlorphenesin (UNII: I670DAL4SZ)
Hydrolyzed Jojoba Esters (Acid Form) (UNII: UDR641JW8W)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Ethylhexyl Stearate (UNII: EG3PA2K3K5)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
Trideceth-6 (UNII: 3T5PCR2H0C)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0576-3	88 mL in 1 TUBE; Type 0: Not a Combination Product	10/07/2019
2	NDC: 69968-0576-5	147 mL in 1 TUBE; Type 0: Not a Combination Product	10/07/2019
3	NDC: 69968-0576-1	29 mL in 1 TUBE; Type 0: Not a Combination Product	10/07/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	10/07/2019

Labeler - Johnson & Johnson Consumer Inc. (002347102)