NEUTROGENA ULTRA SHEER DRY TOUCH SUNSCREEN BROAD SPECTRUM SPF 55 CLUBTRAY- avobenzone, homosalate, octisalate, and octocrylene kit

Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 55 by

Drug Labeling and Warnings

Neutrogena Ultra Sheer Dry Touch Sunscreen Broad Spectrum SPF 55 by is a Otc medication manufactured, distributed, or labeled by Johnson & Johnson Consumer Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Neutrogena® Ultra Sheer® dry-touch sunscreen BROAD SPECTRUM SPF55

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 - Kit Package Label

Neutrogena®

#1 Dermatologist recommended suncare brand

Powerful sun protection,

unbelievably light feel

ACTUAL

SIZES

OXYBENZONE

& OCTINOXATE FREE

helioplex®

broad spectrum uvauvb

NEUTROGENA® ULTRA SHEER® Sunscreen Lotion Broad Spectrum SPF 55

5.0 FL OZ (147 mL) and 3.0 FL OZ (88 mL), TOTAL 8.0 FL OZ (235 mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA ULTRA SHEER DRY TOUCH SUNSCREEN BROAD SPECTRUM SPF 55  CLUBTRAY
avobenzone, homosalate, octisalate, and octocrylene kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0847

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0847-9	1 in 1 PACKAGE	12/08/2023

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	147 mL
Part 2	1 TUBE	88 mL

Part 1 of 2

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

Product Information
Item Code (Source)	NDC: 69968-0576
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	100 mg  in 1 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
PEG-100 STEARATE (UNII: YD01N1999R)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
DOCOSANOL (UNII: 9G1OE216XY)
DIMETHICONE (UNII: 92RU3N3Y1O)
YELLOW WAX (UNII: 2ZA36H0S2V)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CHLORPHENESIN (UNII: I670DAL4SZ)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
WATER (UNII: 059QF0KO0R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0576-5	147 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 Drug	M004	10/07/2019

Part 2 of 2

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

Product Information
Item Code (Source)	NDC: 69968-0576
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 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
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
2-ETHYLHEXYL ACRYLATE, METHACRYLATE, METHYL METHACRYLATE, OR BUTYL METHACRYLATE/HYDROXYPROPYL DIMETHICONE COPOLYMER (30000-300000 MW) (UNII: S7ZA3CCJ4M)
XANTHAN GUM (UNII: TTV12P4NEE)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
JOJOBA OIL, RANDOMIZED (UNII: 7F0EV20QYL)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
BENZYL ALCOHOL (UNII: LKG8494WBH)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
DIMETHICONE/PEG-10/15 CROSSPOLYMER (UNII: 21AS8B1BSS)
ETHYLHEXYL STEARATE (UNII: EG3PA2K3K5)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
PEG-100 STEARATE (UNII: YD01N1999R)
TRIDECETH-6 (UNII: 3T5PCR2H0C)
DOCOSANOL (UNII: 9G1OE216XY)
DIMETHICONE (UNII: 92RU3N3Y1O)
YELLOW WAX (UNII: 2ZA36H0S2V)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
CHLORPHENESIN (UNII: I670DAL4SZ)
BUTYL METHACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID/STYRENE CROSSPOLYMER (UNII: V5RS026Q0H)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
WATER (UNII: 059QF0KO0R)
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)
CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

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

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M004	10/07/2019

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	12/08/2023

Labeler - Johnson & Johnson Consumer Inc. (118772437)