Drug Facts - Softlips Pearl

Drug Facts - Softlips Pearl
SPL v3
SPL
SPL Set ID 43e175b4-7a48-431e-bf27-9ce7dee53f5e
Route
TOPICAL
Published
Effective Date 2018-11-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octinoxate (75 mg) Octisalate (50 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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-02-01

Description

Octinoxate 7.5% Octisalate 5%

Purpose

Octinoxate - Sunscreen Octisalate - Sunscreen


Medication Information

Purpose

Octinoxate - Sunscreen

Octisalate - Sunscreen

Description

Octinoxate 7.5% Octisalate 5%

Uses
  • helps prevent sunburn
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

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
Do Not Use

on damaged or broken skin

Questions?

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

Other Information
  • protect this product from excessive heat and direct sun
Active Ingredients

Octinoxate 7.5%

Octisalate 5%

Inactive Ingredients

lanolin oil, hydrogenated polyisobutene, ozokerite, limnanthes alba (meadowfoam) seed oil, VP/hexadecene copolymer, mineral oil, bis-diglyceryl 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

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

Keep Out of Reach of Children.

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


Structured Label Content

Uses
  • helps prevent sunburn
Purpose

Octinoxate - Sunscreen

Octisalate - Sunscreen

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

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
Do Not Use (Do not use)

on damaged or broken skin

Questions?

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

Other Information (Other information)
  • protect this product from excessive heat and direct sun
Active Ingredients (Active ingredients)

Octinoxate 7.5%

Octisalate 5%

Inactive Ingredients (Inactive ingredients)

lanolin oil, hydrogenated polyisobutene, ozokerite, limnanthes alba (meadowfoam) seed oil, VP/hexadecene copolymer, mineral oil, bis-diglyceryl 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

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

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

rash occurs

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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