NEUTROGENA AGE SHIELD FACE SUNSCREEN BROAD SPECTRUM SPF70- avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Neutrogena Age Shield Face by

Drug Labeling and Warnings

Neutrogena Age Shield Face 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 2.8%
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

• 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, freezing, and direct sun

Inactive ingredients

water, styrene/acrylates copolymer, silica, diethylhexyl 2,6-naphthalate, beeswax, caprylyl methicone, cetyl dimethicone, ethylhexylglycerin, glyceryl stearate, PEG-100 stearate, sodium polyacrylate, caprylyl glycol, acrylates/C12-22 alkyl methacrylate copolymer, ethylhexyl stearate, dimethicone, xanthan gum, trimethylsiloxysilicate, disodium EDTA, tanacetum parthenium (feverfew) leaf/flower/stem juice, dipotassium glycyrrhizate, BHT, trideceth-6, tocopherol, glycine soja (soybean) seed extract, polyaminopropyl biguanide, methylisothiazolinone, fragrance

Questions?

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

PRINCIPAL DISPLAY PANEL - 88 mL Tube Carton

Neutrogena®

Age Shield™
face
lotion

SUNSCREEN
Broad Spectrum
SPF 70

helioplex 360°
full spectrum uva uvb

SUPERIOR ANTI-AGING
PROTECTION

clinically proven potent
anti-oxidant blend

shields skin 6-layers deep
from skin-aging UVA rays

water resistant (80 minutes)

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

3.0 FL. OZ. (88mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA AGE SHIELD FACE   SUNSCREEN BROAD SPECTRUM SPF70
avobenzone, homosalate, octisalate, octocrylene, and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-050
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	150 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	50 mg  in 1 mL
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	28 mg  in 1 mL
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	60 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Diethylhexyl 2,6-Naphthalate (UNII: I0DQJ7YGXM)
Yellow Wax (UNII: 2ZA36H0S2V)
Caprylyl Trisiloxane (UNII: Q95M2P1KJL)
Ethylhexylglycerin (UNII: 147D247K3P)
Glyceryl Monostearate (UNII: 230OU9XXE4)
PEG-100 Stearate (UNII: YD01N1999R)
Caprylyl Glycol (UNII: 00YIU5438U)
Ethylhexyl Stearate (UNII: EG3PA2K3K5)
Dimethicone (UNII: 92RU3N3Y1O)
Xanthan Gum (UNII: TTV12P4NEE)
Edetate Disodium (UNII: 7FLD91C86K)
Feverfew (UNII: Z64FK7P217)
Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Trideceth-6 (UNII: 3T5PCR2H0C)
Tocopherol (UNII: R0ZB2556P8)
Soybean (UNII: L7HT8F1ZOD)
Polihexanide (UNII: 322U039GMF)
Methylisothiazolinone (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-050-03	1 in 1 CARTON	10/01/2013
1		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 NOT FINAL	part352	10/01/2013

Labeler - Johnson & Johnson Consumer Inc. (002347102)