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Softlips

The Mentholatum Company

Drug Facts


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients

Dimethicone 2%

Octinoxate 7.5%

Octisalate 3%

Oxybenzone 3%

Purpose

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Octisalate - Sunscreen

Oxybenzone - Sunscreen

Softlips Uses

  • helps prevent sunburn
  • higher SPF gives more sunburn protection
  • helps prevent and temporarily protects chapped and windburned lips

Warnings

Stop use and ask a doctor if

  • rash or irritation develops and lasts
  • condition worsens or does not improve within 7 days

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • apply liberally before sun exposure and as needed
  • children under 6 months of age: ask a doctor

Inactive ingredients

ozokerite, squalane, ethylhexyl palmitate, petrolatum, myristyl myristate, myristyl lactate, flavor, cetyl alcohol, myristyl laurate, myristyl alcohol, BHT, menthol, tocopheryl acetate [vitamin E]

Questions?

Toll free 1-877-636-2677 MON-FRI 9AM-5PM (EST) softlips.com

Package/Label Principal Display Panel

Softlips

Softlips mint with a hint of vanilla

Lip protectant sunscreen SPF 20

Package/Label Principal Display Panel

Softlips

The Mentholatum Company

Orchard Park, NY 14127

Softlips

dimethicone, octinoxate, octisalate, oxybenzone OINTMENT

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10742-8520
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
DIMETHICONE 20 mg
OCTINOXATE OCTINOXATE 75 mg
OCTISALATE OCTISALATE 30 mg
OXYBENZONE OXYBENZONE 30 mg

Inactive Ingredients

Ingredient Name Strength
Ceresin
SQUALANE
ETHYLHEXYL PALMITATE
petrolatum
MYRISTYL MYRISTATE
MYRISTYL LACTATE
CETYL ALCOHOL
MYRISTYL LAURATE
MYRISTYL ALCOHOL
BUTYLATED HYDROXYTOLUENE
MENTHOL
ALPHA-TOCOPHEROL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 2 in 1 TUBE
2 2 in 1 TUBE
3 NDC:10742-8520-2 2 in 1 TUBE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part352 2010-01-11


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Be sure to consult your doctor before taking any medication!
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