NEUTROGENA ULTRA SHEER FACE MIST SUNSCREEN BROAD SPECTRUM SPF 55- avobenzone, homosalate, octisalate, and octocrylene spray

Neutrogena Ultra Sheer Face Mist Sunscreen Broad Spectrum SPF 55 by

Drug Labeling and Warnings

Neutrogena Ultra Sheer Face Mist 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]

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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 away from face to avoid breathing it
• 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

• Danger: Flammable. Do not use near fire, heat or while smoking. Do not incinerate. Store at temperature below 120°F (48°C).

Directions

• spray liberally and spread evenly by hand 15 minutes before sun exposure
• hold container 4-6 inches from the skin to apply. Rub in.
• do not spray directly into face. Spray on hands and then apply to face. Rub in.
• do not apply in windy conditions
• use in a well-ventilated area
• 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

Alcohol Denat., Dimethicone, Trisiloxane, Diisopropyl Adipate, Acrylates/Octylacrylamide Copolymer, Acrylates/Dimethicone Copolymer, Fragrance, Tocopheryl Acetate

Questions?

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

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

PRINCIPAL DISPLAY PANEL - 100 mL Bottle Label

New
Neutrogena®
#1 DERMATOLOGIST RECOMMENDED BRAND
Ultra Sheer®
Face
mist
sunscreen
BROAD SPECTRUM SPF 55

55
helioplex®
broad spectrum uvauvb
instantly refreshes + protects
invisible finish, oil-free
water resistant (40minutes)

3.4 FL OZ (100 mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA ULTRA SHEER FACE MIST SUNSCREEN BROAD SPECTRUM SPF 55 
avobenzone, homosalate, octisalate, and octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0543
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
ALCOHOL (UNII: 3K9958V90M)
Dimethicone (UNII: 92RU3N3Y1O)
Trisiloxane (UNII: 9G1ZW13R0G)
Diisopropyl Adipate (UNII: P7E6YFV72X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0543-3	100 mL in 1 BOTTLE; 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)