NEUTROGENA TRIPLE AGE REPAIR MOISTURIZER BROAD SPECTRUM SPF25- avobenzone, homosalate, octisalate, and octocrylene cream

Neutrogena Triple Age Repair Moisturizer by

Drug Labeling and Warnings

Neutrogena Triple Age Repair Moisturizer 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 (2%)	Sunscreen
Homosalate (4%)	Sunscreen
Octisalate (4%)	Sunscreen
Octocrylene (2%)	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

For sunscreen use:

• apply liberally and evenly 15 minutes before sun exposure
• reapply at least every 2 hours
• use a water resistant sunscreen if swimming or sweating
• 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 ingredient

Water, Propylene Glycol, Glycerin, Dimethicone, Steareth-2, Ethylhexyl Palmitate, Isononyl Isononanoate, Butyrospermum Parkii (Shea) Butter, Styrene/Acrylates Copolymer, Methyl Methacrylate Crosspolymer, Steareth-21, Hexylresorcinol, Behenyl Alcohol, Bisabolol, Ascorbyl Glucoside, Anhydroxylitol, Xylitol, Xylitylglucoside, Dimethicone Crosspolymer, Caprylyl Glycol, Ammonium Acryloyldimethyltaurate/VP Copolymer, Sclerotium Gum, Disodium EDTA, Sodium Hydroxide, Mica, Titanium Dioxide, Methylparaben, Propylparaben, Ethylparaben, Phenoxyethanol, Fragrance

Questions or comments?

Visit www.neutrogena.com or call toll-free 800-582-4048 or 215-273-8755

SPL UNCLASSIFIED SECTION

Dist. by Neutrogena Corp., L.A., CA 90045

PRINCIPAL DISPLAY PANEL - 48g Jar Carton

NEW

Neutrogena®

Triple Age Repair™
moisturizer

with
sunscreen

Improves look of:

• Wrinkles
• Uneven Tone
• Firmness

HEXINOL™

Broad Spectrum
SPF 25

NET WT. 1.7 OZ. (48g)

INGREDIENTS AND APPEARANCE

NEUTROGENA TRIPLE AGE REPAIR MOISTURIZER   BROAD SPECTRUM SPF25
avobenzone, homosalate, octisalate, and octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-537
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	20 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	40 mg  in 1 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	40 mg  in 1 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM)	Octocrylene	20 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
propylene glycol (UNII: 6DC9Q167V3)
glycerin (UNII: PDC6A3C0OX)
dimethicone (UNII: 92RU3N3Y1O)
steareth-2 (UNII: V56DFE46J5)
ethylhexyl palmitate (UNII: 2865993309)
isononyl isononanoate (UNII: S4V5BS6GCX)
shea butter (UNII: K49155WL9Y)
steareth-21 (UNII: 53J3F32P58)
hexylresorcinol (UNII: R9QTB5E82N)
docosanol (UNII: 9G1OE216XY)
levomenol (UNII: 24WE03BX2T)
ascorbyl glucoside (UNII: 2V52R0NHXW)
anhydroxylitol (UNII: 8XWR7NN42F)
xylitol (UNII: VCQ006KQ1E)
xylitylglucoside (UNII: O0IEZ166FB)
caprylyl glycol (UNII: 00YIU5438U)
ammonium acryloyldimethyltaurate/VP copolymer (UNII: W59H9296ZG)
betasizofiran (UNII: 2X51AD1X3T)
Edetate Disodium (UNII: 7FLD91C86K)
sodium hydroxide (UNII: 55X04QC32I)
mica (UNII: V8A1AW0880)
titanium dioxide (UNII: 15FIX9V2JP)
methylparaben (UNII: A2I8C7HI9T)
propylparaben (UNII: Z8IX2SC1OH)
ethylparaben (UNII: 14255EXE39)
phenoxyethanol (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-537-01	1 in 1 CARTON	10/01/2013
1		48 g in 1 JAR; 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)