NEUTROGENA PURE AND FREE BABY SUNSCREEN BROAD SPECTRUM SPF60 PLUS- titanium dioxide and zinc oxide stick

Neutrogena Pure and Free Baby by

Drug Labeling and Warnings

Neutrogena Pure and Free Baby 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 6%
Zinc Oxide 4.7%

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 generously 15 minutes before sun exposure
• ensure complete coverage to the area above the lip, nose, and tops of ears.
• 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 and direct sun
• may stain some fabrics
• package contains some small parts, which could cause a choking hazard

Inactive Ingredients

Aluminum Hydroxide, Beeswax, BHT, Butyloctyl Salicylate, C12-15 Alkyl Benzoate, Cetyl Alcohol, Dimethicone, Euphorbia Cerifera (Candelilla) Wax, Isostearic Acid, Neopentyl Glycol Diethylhexanoate, Neopentyl Glycol Diisostearate , Ozokerite, Paraffin, Polyethylene, Stearic Acid, Triethoxycaprylylsilane

Questions or comments?

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

SPL UNCLASSIFIED SECTION

Dist. by Neutrogena Corporation, Los Angeles, CA 90045

PRINCIPAL DISPLAY PANEL - 13 g Cylinder Blister Pack

Neutrogena®

pure & free®
baby

SUNSCREEN

Broad Spectrum
SPF 60+

pureSCREEN®
broad spectrum uva uvb

100%
naturally-sourced
sunscreen
ingredients
fragrance free
ideal for
delicate skin
water resistant
(80 minutes)

#1 DERMATOLOGIST RECOMMENDED SUNCARE

NET WT
0.47 OZ
(13g)

INGREDIENTS AND APPEARANCE

NEUTROGENA PURE AND FREE BABY   SUNSCREEN BROAD SPECTRUM SPF60 PLUS
titanium dioxide and zinc oxide stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-324
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	60 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	47 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Aluminum Hydroxide (UNII: 5QB0T2IUN0)
Yellow Wax (UNII: 2ZA36H0S2V)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Butyloctyl Salicylate (UNII: 2EH13UN8D3)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Cetyl Alcohol (UNII: 936JST6JCN)
Dimethicone (UNII: 92RU3N3Y1O)
Candelilla Wax (UNII: WL0328HX19)
Isostearic Acid (UNII: X33R8U0062)
Neopentyl Glycol Diethylhexanoate (UNII: U68ZV6W62C)
Neopentyl Glycol Diisostearate (UNII: 4M6OQ34JWW)
Paraffin (UNII: I9O0E3H2ZE)
High Density Polyethylene (UNII: UG00KM4WR7)
Stearic Acid (UNII: 4ELV7Z65AP)
Triethoxycaprylylsilane (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-324-01	1 in 1 BLISTER PACK	10/22/2012
1		13 g in 1 CYLINDER; 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	10/22/2012

Labeler - Johnson & Johnson Consumer Inc. (002347102)