NEUTROGENA ULTRA SHEER BODY MIST SUNSCREEN BROAD SPECTRUM SPF 70- avobenzone, homosalate, octisalate, and octocrylene spray

Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70 by

Drug Labeling and Warnings

Neutrogena Ultra Sheer Body Mist Sunscreen Broad Spectrum SPF 70 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 15%	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.
  • keep away from face to avoid breathing it

• 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

• Warning: FLAMMABLE. Contents under pressure. Do not use near fire, heat or while smoking. Do not puncture or incinerate. Store at temperature below 120°F (48°C). Use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

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., Isobutane, Butyloctyl Salicylate, Dicaprylyl Carbonate, Diethylhexyl 2,6-Naphthalate, Polyester-7, Acrylates/Octylacrylamide Copolymer, Neopentyl Glycol Diheptanoate, Fragrance, Tocopheryl Acetate

Questions or Comments?

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 - 141 g Can Label

NEW LOOK

Neutrogena ®

DERMATOLOGIST RECOMMENDED BRAND

ULTRA

SHEER ®

Body Mist

Sunscreen

70

BROAD SPECTRUM SPF 70

Antioxidant Vitamin E

Lightweight clean feel

Shields skin 6 layers deep

with helioplex ®

Water resistant (80 minutes)

NET WT 5.0 OZ (141 g)

INGREDIENTS AND APPEARANCE

NEUTROGENA ULTRA SHEER BODY MIST SUNSCREEN BROAD SPECTRUM SPF 70 
avobenzone, homosalate, octisalate, and octocrylene spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69968-0663
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 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
DIETHYLHEXYL 2,6-NAPHTHALATE (UNII: I0DQJ7YGXM)
POLYESTER-7 (UNII: 0841698D2F)
ACRYLATE/ISOBUTYL METHACRYLATE/N-TERT-OCTYLACRYLAMIDE COPOLYMER (75000 MW) (UNII: JU3XHR8VWK)
NEOPENTYL GLYCOL DIHEPTANOATE (UNII: 5LKW3C543X)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
ALCOHOL (UNII: 3K9958V90M)
ISOBUTANE (UNII: BXR49TP611)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69968-0663-5	141 g in 1 CAN; Type 0: Not a Combination Product	10/05/2020
2	NDC: 69968-0663-3	3 in 1 CARTON	10/05/2020
2		141 g in 1 CAN; Type 0: Not a Combination Product
3	NDC: 69968-0663-2	2 in 1 CARTON	10/05/2020
3		141 g in 1 CAN; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M020	10/05/2020

Labeler - Kenvue Brands LLC (118772437)