Neutrogena Revitalizing Lip Balm description, usages, side effects, indications, overdosage, supplying and lots more!

Neutrogena Revitalizing Lip Balm

Neutrogena Corporation

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert
Neutrogena Revitalizing Lip Balm with Sunscreen SPF 20 Petal Glow 40

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredients

Octinoxate 7.5%, Oxybenzone 5%

Purpose

Sunscreen

Uses

  • Helps prevent sunburn

Warnings

  • Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.
  • 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

For Sunscreen Use

  • apply liberally 15 minutes before sun exposure
  • use a water resistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children under 6 months of age: Ask a doctor

Other information

  • protect this product from excessive heat and direct sun
  • may stain some fabrics

Inactive ingredients

Hydrogenated Polyisobutene, Petrolatum, Polybutene, Phenyl Trimethicone, Hydrogenated Lanolin, Ozokerite, Myristyl Myristate, Polyethylene, Cetyl Lactate, Butyrospermum Parkii (Shea) Butter, Bis-Behenyl/Isostearyl/Phytosteryl Dimer Dilinoleyl Dimer Dilinoleate, Euphorbia Cerifera (Candelilla) Wax, Silica, Zinc, Stearoxymethicone/Dimethicone Copolymer, Copernicia Cerifera (Carnauba) Wax, Synthetic Wax, Ethylhexyl Palmitate, Tribehenin, Sorbitan Isostearate, Palmitoyl Oligopeptide, Silica Silylate, Flavor, Pentaerythrityl Tetra-di-t-butyl Hydroxyhydrocinnamate, Isopropyl Titanium Triisostearate, Aluminum Hydroxide, Stearic Acid, Copper Powder, Mica, Titanium Dioxide, Iron Oxides, Yellow 5 Lake, Red 7

Questions or comments?

Call toll-free 800-480-4812 or 215-273-8755 (collect) or visit www.neutrogena.com

PRINCIPAL DISPLAY PANEL - 4.2g Tube Blister Pack

PETAL
GLOW 40
SHEER TINT

revitalizing
lip balm

with
sunscreen
SPF20
Softer, rosier & healthier-looking
lips, even after you take it off!

Dramatization

before         after

Neutrogena®

NET WT. 0.15 OZ. (4.2g)

PRINCIPAL DISPLAY PANEL - 4.2g Tube Blister Pack

Neutrogena Revitalizing Lip Balm

Octinoxate and Oxybenzone LIPSTICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10812-013
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
OCTINOXATE OCTINOXATE 75 mg
OXYBENZONE OXYBENZONE 50 mg

Inactive Ingredients

Ingredient Name Strength
petrolatum
PHENYL TRIMETHICONE
Lanolin Alcohols
MYRISTYL MYRISTATE
HIGH DENSITY POLYETHYLENE
Cetyl Lactate
SHEA BUTTER
CANDELILLA WAX
SILICON DIOXIDE
Zinc
carnauba wax
ETHYLHEXYL PALMITATE
tribehenin
Sorbitan Isostearate
PALMITOYL OLIGOPEPTIDE
PENTAERYTHRITOL TETRAKIS(3-(3,5-DI-TERT-BUTYL-4-HYDROXYPHENYL)PROPIONATE)
ISOPROPYL TITANIUM TRIISOSTEARATE
aluminum hydroxide
STEARIC ACID
Copper
MICA
titanium dioxide
FD&C YELLOW NO. 5
ALUMINUM OXIDE
D&C RED NO. 7

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 4.2 in 1 TUBE
2 NDC:10812-013-01 1 in 1 BLISTER PACK

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2010-12-01


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