OTC Medication Information: Softlips Pearl Plus Vanilla

SOFTLIPS PEARL PLUS VANILLA- dimethicone, octinoxate, octisalate, oxybenzone
The Mentholatum Company

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.

Softlips Pearl

Drug Facts

Active ingredient

Octinoxate 7.5%

Octisalate 5%

Purpose

Octinoxate – Sunscreen

Octisalate — Sunscreen

Uses

  • helps prevent sunburn

Warnings

Skin Cancer/Skin Agent 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.

Dosage and Administration

  • 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

Other information

  • protect this product from excessive heat and direct sun

Inactive ingredients

lanolin oil, hydrogenated polyisobutene, ozokerite, limnanthes alba (meadowfoam) seed oil, VP/hexadecane copolymer, mineral oil, bis-diglycerl polyacyladipate-2, oleyl alcohol, copernicia cerifera (carnauba) wax, ricinus communis (castor) seed oil, cetyl lactate, polyethylene, paraffin, ammonium glycyrrhizate, BHT, flavor, magnesium stearate, menthol, tocopheryl acetate [vitamin E], bismuth oxychloride, carmine, mica, titanium dioxide

Questions or comments?

1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

Softlips.com

Softlips Vanilla

Drug Facts

Active Ingredient

Dimethicone 2%

Octinoxate 7.5%

Octisalate 3%

Oxybenzone 3%

Purpose

Dimethicone – Skin protectant

Octinoxate – Sunscreen

Octisalate – Sunscreen

Oxybenzone — Sunscreen

Uses

  • helps prevent sunburn
  • temporarily protects chapped or cracked lips

Warnings

Skin Cancer/Skin Agent 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.

Dosage and Administration

  • 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

Other information

  • protect this product from excessive heat and direct sun

Inactive ingredients

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

Questions or comments?

1-877-636-2677 MON-FRI 9 AM to 5 PM (EST)

Softlips.com

Principal Display Panel

Front Blistercard
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Principal Display Panel

Back Blistercard
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SOFTLIPS PEARL PLUS VANILLA
dimethicone, octinoxate, octisalate, oxybenzone kit
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:10742-7011
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:10742-7011-1 1 KIT in 1 PACKAGE None
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 CYLINDER 1 g
Part 2 1 CYLINDER 1 g
Part 1 of 2
SOFTLIPS PEARL
octinoxate, octisalate stick
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg in 1 g
OCTISALATE (OCTISALATE) OCTISALATE 50 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
LANOLIN OIL
HYDROGENATED POLYBUTENE (1300 MW)
CERESIN
MEADOWFOAM SEED OIL
VINYLPYRROLIDONE/HEXADECENE COPOLYMER
MINERAL OIL
BIS-DIGLYCERYL POLYACYLADIPATE-2
OLEYL ALCOHOL
CARNAUBA WAX
CASTOR OIL
CETYL LACTATE
PARAFFIN
AMMONIUM GLYCYRRHIZATE
BUTYLATED HYDROXYTOLUENE
MAGNESIUM STEARATE
MENTHOL, UNSPECIFIED FORM
.ALPHA.-TOCOPHEROL
BISMUTH OXYCHLORIDE
CARMINIC ACID
MICA
TITANIUM DIOXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 2 g in 1 CYLINDER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 02/01/2010
Part 2 of 2
SOFTLIPS VANILLA
dimethicone, octinoxate, octisalate, oxybenzone stick
Product Information
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
DIMETHICONE (DIMETHICONE) DIMETHICONE 20 mg in 1 g
OCTINOXATE (OCTINOXATE) OCTINOXATE 75 mg in 1 g
OCTISALATE (OCTISALATE) OCTISALATE 30 mg in 1 g
OXYBENZONE (OXYBENZONE) OXYBENZONE 30 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CERESIN
SQUALANE
ETHYLHEXYL PALMITATE
PETROLATUM
MYRISTYL MYRISTATE
MYRISTYL LACTATE
CETYL ALCOHOL
MYRISTYL LAURATE
MYRISTYL ALCOHOL
BUTYLATED HYDROXYTOLUENE
MENTHOL, UNSPECIFIED FORM
.ALPHA.-TOCOPHEROL
Packaging
# Item Code Package Description Multilevel Packaging
1 2 g in 1 CYLINDER None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 11/19/1997
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 01/02/2017
Labeler — The Mentholatum Company (002105757)
Registrant — The Mentholatum Company (002105757)
Establishment
Name Address ID/FEI Operations
The Mentholatum Company 002105757 manufacture (10742-7011)

Revised: 02/2023 The Mentholatum Company

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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