Sun Shades Lip Balm description, usages, side effects, indications, overdosage, supplying and lots more!

Sun Shades Lip Balm

Melaleuca Inc.
Melaleuca Inc.

  • 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
Sun Shades Lip Balm - SunscreenStrawberry Tart - Broad-spectrum SPF 15

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients

Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 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 dcotor 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

■ reapply at least every 2 hours ■ use a water-resistant sunscreen if swimming or sweating ■ children under 6 months of age: ask a doctor

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-sleeve shirts, pants, hats, and sunglasses

Other information

■ dermatologist and allergy tested

■ protect this product from excessive heat and direct sun ■ do not store at temperatures below 32 F (0C) or above 120F (48C)

Inactive Ingredients

ammonium glycyrrhizate, beeswax, C12-15 alkyl benzoate, cetyl esters, ethylene/VA copolymer, euphorbia cerifera (candillia) wax, flavor petrolatum USP, simmondsia chinensis (jojoba) seed oil, stearyl dimethicone, theobroma cacao (cocoa) seed butter, tocopheryl acetate (vitamin E USP)

Sun Shades Lip Balm

Avobenzone 2.5%, Octinoxate 6%, Oxybenzone 3% STICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:54473-254
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
AVOBENZONE AVOBENZONE 0.1175 g
OCTINOXATE OCTINOXATE 0.282 g
OXYBENZONE OXYBENZONE 0.141 g

Inactive Ingredients

Ingredient Name Strength
ALKYL (C12-15) BENZOATE
ALPHA-TOCOPHEROL ACETATE
AMMONIUM GLYCYRRHIZATE
Ceresin
CETYL ESTERS WAX
COCOA BUTTER
ETHYLENE-VINYL ACETATE COPOLYMER (40% VINYL ACETATE)
Jojoba Oil
petrolatum
YELLOW WAX
CANDELILLA WAX

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:54473-254-01 4.25 in 1 APPLICATOR

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2012-08-01


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