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

Neutrogena Pure and Free Baby Sunscreen by

Drug Labeling and Warnings

Neutrogena Pure and Free Baby Sunscreen 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 8%
Zinc Oxide 6.8%

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 liberally 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

Beeswax, BHT, C12-15 Alkyl Benzoate, Dimethicone, Dipropylene Glycol Dibenzoate, Euphorbia Cerifera (Candelilla) Wax, Octyldodecyl Neopentanoate, Ozokerite, Paraffin, Phenyl Trimethicone, Polyethylene, Polyhydroxystearic Acid, PPG-15 Stearyl Ether Benzoate, Triethoxycaprylylsilane

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 13 g Cylinder Blister Pack

Neutrogena®
pure & free®
baby
SUNSCREEN

Broad Spectrum
SPF 60+
pureSCREEN®
broad spectrum uvauvb

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

NET WT
0.47 oz
(13 g)

#1 DERMATOLOGIST RECOMMENDED SUNCARE

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: 10812-443
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	80 mg  in 1 g
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	68 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Yellow Wax (UNII: 2ZA36H0S2V)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Dimethicone (UNII: 92RU3N3Y1O)
Dipropylene Glycol Dibenzoate (UNII: 6OA5ZDY41O)
Candelilla Wax (UNII: WL0328HX19)
Octyldodecyl Neopentanoate (UNII: X8725R883T)
Paraffin (UNII: I9O0E3H2ZE)
Phenyl Trimethicone (UNII: DR0K5NOJ4R)
High Density Polyethylene (UNII: UG00KM4WR7)
PPG-15 Stearyl Ether Benzoate (UNII: 80D2J6361M)
Triethoxycaprylylsilane (UNII: LDC331P08E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-443-01	1 in 1 BLISTER PACK	01/03/2013
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	01/03/2013

Labeler - Johnson & Johnson Consumer Inc. (002347102)