Softlips Pearl Plus Vanilla

Softlips Pearl Plus Vanilla
SPL v3
SPL
SPL Set ID 107bcaa9-4347-4979-be44-35183a9ee67e
Route
TOPICAL
Published
Effective Date 2021-07-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Octisalate (50 mg) Dimethicone (20 mg) Oxybenzone (30 mg)
Inactive Ingredients
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 Squalane Ethylhexyl Palmitate Petrolatum Myristyl Myristate Myristyl Lactate Cetyl Alcohol Myristyl Laurate Myristyl Alcohol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2017-01-02
Description

Softlips Pearl Drug Facts

Purpose

Octinoxate – Sunscreen Octisalate - Sunscreen

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

Medication Information

Purpose

Octinoxate – Sunscreen

Octisalate - Sunscreen

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
Description

Softlips Pearl Drug Facts

Uses
  • helps prevent sunburn
Section 42229-5

Softlips Pearl

Drug Facts

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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

Do Not Use

on damaged or broken skin

When Using

this product keep out of eyes. Rinse with water to remove.

Active Ingredient

Dimethicone 2%

Octinoxate 7.5%

Octisalate 3%

Oxybenzone 3%

Active Ingredient

Octinoxate 7.5%

Octisalate 5%

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

Principal Display Panel
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

Structured Label Content

Uses
  • helps prevent sunburn
Section 42229-5 (42229-5)

Softlips Pearl

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Purpose

Octinoxate – Sunscreen

Octisalate - Sunscreen

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

Do Not Use (Do not use)

on damaged or broken skin

When Using

this product keep out of eyes. Rinse with water to remove.

Active Ingredient

Dimethicone 2%

Octinoxate 7.5%

Octisalate 3%

Oxybenzone 3%

Active Ingredient (Active ingredient)

Octinoxate 7.5%

Octisalate 5%

Other Information (Other information)
  • protect this product from excessive heat and direct sun
Inactive Ingredients (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? (Questions or comments?)

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

Softlips.com

Principal Display Panel
When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

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
Stop Use and Ask A Doctor If (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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:51.853923 · Updated: 2026-03-14T23:05:56.026643