NEUTROGENA PURE AND FREE BABY FACES ULTRA GENTLE SUNSCREEN BROAD SPECTRUM SPF45 PLUS- titanium dioxide and zinc oxide lotion

Neutrogena Pure and Free Baby Faces by

Drug Labeling and Warnings

Neutrogena Pure and Free Baby Faces 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

Titanium Dioxide 5.1%
Zinc Oxide 2.9%

Purpose

Sunscreen

Uses

• Helps prevent sunburn
• (Optional) 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
• 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 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: Ask a doctor

Other information

• Protect this product from excessive heat and direct sun
• May stain some fabrics

Inactive Ingredients

Aluminum Hydroxide, C12-15 Alkyl Benzoate, Carbomer, Cetyl Alcohol, Cetyl Dimethicone, Cetyl Hydroxyethylcellulose, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, Dimethicone Crosspolymer , Dimethicone/Vinyl Dimethicone Crosspolymer, Disodium Phosphate, Ethylhexylglycerin, Glycerin, Hexyl Laurate, Hydrated Silica, Isopropyl Myristate, Magnesium Sulfate, Phenoxyethanol, Polyglyceryl-4 Isostearate, Silica, Sodium Hydroxide, Sodium Phosphate, Stearic Acid, Styrene/Acrylates Copolymer, riethoxycaprylylsilane, Trisiloxane, Water

Questions or comments?

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

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Dist. by Neutrogena Corporation Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 73 mL Tube Carton

Neutrogena®

pure & free®
baby faces
ultra gentle cream

SUNSCREEN
Broad Spectrum
SPF 45+

pureSCREEN®
broad spectrum uva-uvb

TEAR FREE
100% naturally sourced sunscreens
hypoallergenic
water resistant (80 minutes)

#1 DERMATOLOGIST
RECOMMENDED SUNCARE

2.5 FL OZ (73mL)

INGREDIENTS AND APPEARANCE

NEUTROGENA PURE AND FREE BABY FACES   ULTRA GENTLE SUNSCREEN BROAD SPECTRUM SPF45 PLUS
titanium dioxide and zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-420
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	51 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	29 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Cetyl Alcohol (UNII: 936JST6JCN)
CETYL DIMETHICONE 25 (UNII: U4AS1BW4ZB)
Dimethicone (UNII: 92RU3N3Y1O)
DIMETHICONE CROSSPOLYMER (450000 MPA.S AT 12% IN CYCLOPENTASILOXANE) (UNII: UF7620L1W6)
Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F)
Ethylhexylglycerin (UNII: 147D247K3P)
Glycerin (UNII: PDC6A3C0OX)
Hexyl Laurate (UNII: 4CG9F9W01Q)
Hydrated Silica (UNII: Y6O7T4G8P9)
Isopropyl Myristate (UNII: 0RE8K4LNJS)
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB)
Phenoxyethanol (UNII: HIE492ZZ3T)
Polyglyceryl-4 Isostearate (UNII: 820DPX33S7)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Sodium Hydroxide (UNII: 55X04QC32I)
sodium Phosphate (UNII: SE337SVY37)
Stearic Acid (UNII: 4ELV7Z65AP)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Trisiloxane (UNII: 9G1ZW13R0G)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-420-01	1 in 1 CARTON	06/13/2012
1		73 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	06/13/2012

Labeler - Johnson & Johnson Consumer Inc. (002347102)