NEUTROGENA ULTRA GENTLE SOOTHING SUNSCREEN BROAD SPECTRUM SPF15- avobenzone, octinoxate, and octisalate lotion

Neutrogena Ultra Gentle Soothing by

Drug Labeling and Warnings

Neutrogena Ultra Gentle Soothing 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%
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

Apply to face and neck in the morning.

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, Dimethicone, Trisiloxane, Glycerin, Arachidyl Alcohol, Phenyl Trimethicone, Cetearyl Glucoside, Phenoxyethanol, Ethylene/Acrylic Acid Copolymer, Benzyl Alcohol, Propylene Glycol, Behenyl Alcohol, Steareth-2, Sodium Cocoyl Amino Acids, Butylene Glycol, Fragrance, Steareth-21, Polyacrylamide, Arachidyl Glucoside, Disodium EDTA, Chrysanthemum Parthenium (Feverfew) Flower/Leaf/Stem Juice, Chlorphenesin, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Propylparaben, C13-14 Isoparaffin, Ethylparaben, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Sarcosine, Laureth-7, Artemisia Abrotanum Flower/Leaf/Stem Extract, Sodium Hydroxide , Chamomilla Recutita (Matricaria) Flower Extract, Potassium Aspartate, Magnesium Aspartate, Codium Tomentosum Extract

Questions?

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 - 118 mL Bottle Carton

ultra gentle
soothing
lotion
with
sunscreen

Broad Spectrum
SPF 15

UVA/UVB protection

Clinically proven to
Instantly soothe even
The most sensitive skin

Visibly reduces redness

Neutrogena®

DERMATOLOGIST RECOMMENDED

4.0 FL OZ (118mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA ULTRA GENTLE SOOTHING   SUNSCREEN BROAD SPECTRUM SPF15
avobenzone, octinoxate, and octisalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-531
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)
Dimethicone (UNII: 92RU3N3Y1O)
Trisiloxane (UNII: 9G1ZW13R0G)
Glycerin (UNII: PDC6A3C0OX)
Arachidyl Alcohol (UNII: 1QR1QRA9BU)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
Cetearyl Glucoside (UNII: 09FUA47KNA)
Phenoxyethanol (UNII: HIE492ZZ3T)
ACRYLIC ACID/ETHYLENE COPOLYMER (600 MPA.S) (UNII: 1PEZ3NLY6I)
Benzyl Alcohol (UNII: LKG8494WBH)
Propylene Glycol (UNII: 6DC9Q167V3)
Docosanol (UNII: 9G1OE216XY)
Steareth-2 (UNII: V56DFE46J5)
Butylene Glycol (UNII: 3XUS85K0RA)
Steareth-21 (UNII: 53J3F32P58)
Arachidyl Glucoside (UNII: 6JVW35JOOJ)
Edetate Disodium (UNII: 7FLD91C86K)
Feverfew (UNII: Z64FK7P217)
Chlorphenesin (UNII: I670DAL4SZ)
Propylparaben (UNII: Z8IX2SC1OH)
C13-14 Isoparaffin (UNII: E4F12ROE70)
Ethylparaben (UNII: 14255EXE39)
Pentaerythritol Tetrakis(3-(3,5-Di-Tert-Butyl-4-Hydroxyphenyl)Propionate) (UNII: 255PIF62MS)
Sarcosine (UNII: Z711V88R5F)
Laureth-7 (UNII: Z95S6G8201)
Artemisia Abrotanum Flowering Top (UNII: QG07G580U0)
Sodium Hydroxide (UNII: 55X04QC32I)
MATRICARIA CHAMOMILLA FLOWERING TOP (UNII: 3VNC7T6Z02)
Potassium Aspartate (UNII: OC4598NZEQ)
Magnesium Aspartate (UNII: R17X820ROL)
Codium Tomentosum (UNII: B8B45BRU87)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-531-01	1 in 1 CARTON	09/21/2012
1		118 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	09/21/2012

Labeler - Johnson & Johnson Consumer Inc. (002347102)