NEUTROGENA SPECTRUM PLUS ADVANCED SUNSCREEN BROAD SPECTRUM SPF100 PLUS- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, spray

Neutrogena Spectrum Plus Advanced by

Drug Labeling and Warnings

Neutrogena Spectrum Plus Advanced by is a Otc medication manufactured, distributed, or labeled by Neutrogena Corporation, Johnson & Johnson Consumer Products Company, Division of Johnson & Johnson Consumer Companies, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

• spray liberally and spread evenly by hand 15 minutes before sun exposure
• apply to all skin exposed to the sun
• 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 value of SPF 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

Acrylates/Dimethicone Copolymer, Acrylates/Octylacrylamide Copolymer, Alcohol Denat. , Ascorbyl Palmitate, Butyloctyl Salicylate, Camellia Sinensis Leaf Extract, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice, Dimethicone, Ferula Assa Foetida Root Extract, Fragrance, Hibiscus Sabdariffa Flower Extract, Isobutane, Octyldodecyl Neopentanoate, Pyrus Communis (Pear) Fruit Extract, Retinyl Palmitate, Tocopheryl Acetate

Questions or comments?

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

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Dist. by Neutrogena Corp., Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 141 g Can Label

Neutrogena®

Spectrum +

ADVANCED

SUNSCREEN
Broad Spectrum
SPF 100+

helioplex 360°
full spectrum uva uvb

advanced antioxidant complex
water resistant (80 minutes)

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

NET WT 5.0 OZ (141 g)

INGREDIENTS AND APPEARANCE

NEUTROGENA SPECTRUM PLUS ADVANCED   SUNSCREEN BROAD SPECTRUM SPF100 PLUS
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone aerosol, spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-432
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
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	60 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ALCOHOL (UNII: 3K9958V90M)
Ascorbyl Palmitate (UNII: QN83US2B0N)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Green Tea Leaf (UNII: W2ZU1RY8B0)
Dimethicone (UNII: 92RU3N3Y1O)
Ferula Assa-Foetida Root (UNII: 3U9288P88T)
Hibiscus Sabdariffa Flower (UNII: 45TGG6IU6M)
Isobutane (UNII: BXR49TP611)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Pear (UNII: 2ZN8DWC0YF)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-432-01	141 g in 1 CAN; Type 0: Not a Combination Product	10/22/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	10/22/2012

Labeler - Johnson & Johnson Consumer Inc. (002347102)