Softlips Sugar and Spice description, usages, side effects, indications, overdosage, supplying and lots more!

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Softlips Sugar and Spice

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 Sugar and Spice Uses

  • •helps prevent sunburn
  • •temporarily protects chapped or cracked lips

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 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
  • •condition worsens
  • •symptoms last more than 7 days or clear up and occur again within a few days

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

Softlips Sugar and Spice Other information

protect this product from excessive heat and direct sun

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 9 AM to 5 PM (EST) softlips.com

Package/Label Principal Display Panel

Principal Display Panel

Softlips Sugar and Spice

Dimethicone, Octinoxate, Octisalate, Oxybenzone STICK

Product Information

Product Type Human otc drug label Item Code (Source) NDC:10742-8507
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 ACETATE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 2 in 1 TUBE
2 NDC:10742-8507-1 1 in 1 BLISTER PACK

Marketing Information

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


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