NEUTROGENA BEACH DEFENSE SUNSCREEN BROAD SPECTRUM SPF50 PLUS- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone stick

Neutrogena Beach Defense by

Drug Labeling and Warnings

Neutrogena Beach Defense 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 ingredients

Avobenzone 3%
Homosalate 15%
Octisalate 5%
Octocrylene 10%
Oxybenzone 3%

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

• apply generously 15 minutes before sun exposure
• ensure complete coverage to the area above the lip, nose, and tops of ears.
• 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
• package contains some small parts, which could cause a choking hazard

Inactive ingredients

Adipic Acid/Diglycol Crosspolymer, Beeswax, BHT, C12-15 Alkyl Benzoate, Diethylhexyl 2,6-Naphthalate, Dimethicone, Fragrance, Neopentyl Glycol Diethylhexanoate, Neopentyl Glycol Diisostearate, Octyldodecyl Neopentanoate, Ozokerite, Paraffin, Polyethylene

Questions or comments?

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

SPL UNCLASSIFIED SECTION

Dist. by Neutrogena Corp. Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 42 g Canister Label

Neutrogena®

Beach
Defense®
water + sun protection

sunscreen stick
Broad Spectrum SPF50 +

50+

helioplex
broad spectrum uvauvb

NET WT 1.5 OZ (42g)

INGREDIENTS AND APPEARANCE

NEUTROGENA BEACH DEFENSE   SUNSCREEN BROAD SPECTRUM SPF50 PLUS
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-445
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	30 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ADIPIC ACID/DIGLYCOL CROSSPOLYMER (20000 MPA.S) (UNII: R9TPS68K19)
Yellow Wax (UNII: 2ZA36H0S2V)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)
Dimethicone (UNII: 92RU3N3Y1O)
Neopentyl Glycol Diethylhexanoate (UNII: U68ZV6W62C)
Neopentyl Glycol Diisostearate (UNII: 4M6OQ34JWW)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
CERESIN (UNII: Q1LS2UJO3A)
Paraffin (UNII: I9O0E3H2ZE)
High Density Polyethylene (UNII: UG00KM4WR7)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-445-01	42 g in 1 CANISTER; Type 0: Not a Combination Product	09/13/2013

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH NOT FINAL	part352	09/13/2013

Labeler - Johnson & Johnson Consumer Inc. (002347102)