Neutrogena Pure & Free Liquid Sunscreen Broad Spectrum SPF 50

Drug Labeling and Warnings

Drug Details [pdf]

NEUTROGENA PURE AND FREE  SUNSCREEN BROAD SPECTRUM SPF50- titanium dioxide and zinc oxide liquid 
Johnson & Johnson Consumer Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Neutrogena Pure & Free Liquid Sunscreen
Broad Spectrum SPF 50

Drug Facts

Active ingredients

Titanium Dioxide 5%
Zinc Oxide 3%

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
• 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 age: Ask a doctor

Other information

• Protect this product from excessive heat and direct sun

Inactive Ingredients

BHT, Bisabolol, C12-15 Alkyl Benzoate, Caprylyl Glycol, Cetyl PEG/PPG-10/1 Dimethicone, Dimethicone, DMDM Hydantoin, Magnesium Sulfate, Polyglyceryl-4 Diisostearate/Polyhydroxystearate/Sebacate, PPG-12/SMDI Copolymer, Silica, Styrene/Acrylates Copolymer, Triethoxycaprylylsilane, Trisiloxane, Water

Questions or comments?

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

PRINCIPAL DISPLAY PANEL - 40 mL Tube Label

Neutrogena®

pure & free™
liquid
SUNSCREEN
Broad Spectrum
SPF50

purescreen®
broad spectrum uvauvb

100%
naturally sourced
sunscreens

layers invisibly
under makeup

weightless liquid
formula
water resistant
(80 minutes)

1.4 FL OZ (40mL)

#1 DERMATOLOGIST RECOMMENDED SUNCARE

NEUTROGENA PURE AND FREE   SUNSCREEN BROAD SPECTRUM SPF50
titanium dioxide and zinc oxide liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10812-430
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Titanium Dioxide (UNII: 15FIX9V2JP) (Titanium Dioxide - UNII:15FIX9V2JP)	Titanium Dioxide	50 mg  in 1 mL
Zinc Oxide (UNII: SOI2LOH54Z) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	30 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Levomenol (UNII: 24WE03BX2T)
Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ)
Caprylyl Glycol (UNII: 00YIU5438U)
Dimethicone (UNII: 92RU3N3Y1O)
DMDM Hydantoin (UNII: BYR0546TOW)
Magnesium Sulfate, Unspecified Form (UNII: DE08037SAB)
Silicon Dioxide (UNII: ETJ7Z6XBU4)
Triethoxycaprylylsilane (UNII: LDC331P08E)
Trisiloxane (UNII: 9G1ZW13R0G)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10812-430-01	1 in 1 BLISTER PACK	10/16/2012	11/01/2019
1		40 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	10/16/2012	11/01/2019

Labeler - Johnson & Johnson Consumer Inc. (002347102)

Revised: 11/2017

Document Id: 18eba45d-96b6-42ad-af4e-f0eb038a3d30

34390-5

Set id: 328ac9b6-ccf4-43be-a7c1-f478ad2c44e1

Version: 2

Effective Time: 20171130