NEUTROGENA HEALTHY SKIN RADIANCE SUNSCREEN BROAD SPECTRUM SPF15- avobenzone, octinoxate, and octisalate lotion

Neutrogena Healthy Skin Radiance by

Drug Labeling and Warnings

Neutrogena Healthy Skin Radiance 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%
Octinoxate 7.5%
Octisalate 2%

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

For Sunscreen Use

•  
  • apply generously 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 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

Inactive Ingredients

Water, C12-15 Alkyl Benzoate, Cetearyl Alcohol, Glycine Soja (Soybean) Seed Extract, Dimethicone, Glycerin, Bis-Phenylpropyl Dimethicone, Phenoxyethanol, Arachidyl Alcohol, Cetearyl Glucoside, Panthenol, Benzyl Alcohol, Ethylene/Acrylic Acid , Copolymer, Behenyl Alcohol, Steareth-2, Fragrance, Steareth-21, Titanium Dioxide, Mica, Polyacrylamide, Polymethyl Methacrylate, Arachidyl Glucoside, Disodium EDTA, Methylparaben, C13-14 Isoparaffin, Propylparaben, Ethylparaben, Laureth-7, Silica, Benzalkonium Chloride, Iodopropynyl Butylcarbamate, BHT

Questions or comments?

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

SPL UNCLASSIFIED SECTION

Dist. by Neutrogena Corp.
Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 73mL Bottle Carton

NEUTROGENA

Healthy Skin®
Radiance
cream

With
SUNSCREEN

Broad Spectrum
SPF 15

boosts radiance

A Radiance Boosting Moisturizer
with Vitamin and Soy

• Instantly improves radiance
  and visibly evens skin tone and
  texture for younger looking skin

Neutrogena®

DERMATOLOGIST
RECOMMENDED

2.5 FL. OZ. (73mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA HEALTHY SKIN RADIANCE   SUNSCREEN BROAD SPECTRUM SPF15
avobenzone, octinoxate, and octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-424
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
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 mL
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W)	Octisalate	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Soybean (UNII: L7HT8F1ZOD)
Dimethicone (UNII: 92RU3N3Y1O)
Glycerin (UNII: PDC6A3C0OX)
BIS-PHENYLPROPYL DIMETHICONE (15 CST) (UNII: 4836494CFT)
Phenoxyethanol (UNII: HIE492ZZ3T)
Arachidyl Alcohol (UNII: 1QR1QRA9BU)
Cetearyl Glucoside (UNII: 09FUA47KNA)
Panthenol (UNII: WV9CM0O67Z)
Benzyl Alcohol (UNII: LKG8494WBH)
Docosanol (UNII: 9G1OE216XY)
Steareth-2 (UNII: V56DFE46J5)
Steareth-21 (UNII: 53J3F32P58)
Titanium Dioxide (UNII: 15FIX9V2JP)
POLY(METHYL METHACRYLATE; 450000 MW) (UNII: Z47NNT4J11)
Arachidyl Glucoside (UNII: 6JVW35JOOJ)
Edetate Disodium (UNII: 7FLD91C86K)
Methylparaben (UNII: A2I8C7HI9T)
C13-14 Isoparaffin (UNII: E4F12ROE70)
Propylparaben (UNII: Z8IX2SC1OH)
Ethylparaben (UNII: 14255EXE39)
Laureth-7 (UNII: Z95S6G8201)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Benzalkonium Chloride (UNII: F5UM2KM3W7)
Iodopropynyl Butylcarbamate (UNII: 603P14DHEB)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-424-02	1 in 1 CARTON	08/02/2012
1		73 mL in 1 BOTTLE, PUMP; 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	08/02/2012

Labeler - Johnson & Johnson Consumer Inc. (002347102)