SOFTLIPS PEARL- octinoxate, octisalate stick

Softlips Pearl by

Drug Labeling and Warnings

Softlips Pearl by is a Otc medication manufactured, distributed, or labeled by The Mentholatum Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Octinoxate 7.5%

Octisalate 5%

Purpose

Octinoxate - Sunscreen

Octisalate - Sunscreen

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

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

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

Other information

• protect this product from excessive heat and direct sun

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

Questions?

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

Principal Display Panel

Principal Display Panel

INGREDIENTS AND APPEARANCE

SOFTLIPS PEARL 
octinoxate, octisalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10742-8573
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	50 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN OIL (UNII: OVV5IIJ58F)
HYDROGENATED POLYBUTENE (1300 MW) (UNII: 7D1YQ9Y5EZ)
CERESIN (UNII: Q1LS2UJO3A)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)
MINERAL OIL (UNII: T5L8T28FGP)
BIS-DIGLYCERYL POLYACYLADIPATE-2 (UNII: 6L246LAM9T)
OLEYL ALCOHOL (UNII: 172F2WN8DV)
CARNAUBA WAX (UNII: R12CBM0EIZ)
CASTOR OIL (UNII: D5340Y2I9G)
CETYL LACTATE (UNII: A7EVH2RK4O)
PARAFFIN (UNII: I9O0E3H2ZE)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
BISMUTH OXYCHLORIDE (UNII: 4ZR792I587)
CARMINIC ACID (UNII: CID8Z8N95N)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10742-8573-1	1 in 1 BLISTER PACK	02/01/2010
1		2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	02/01/2010

Labeler - The Mentholatum Company (002105757)

Registrant - The Mentholatum Company (002105757)

Establishment
Name	Address	ID/FEI	Business Operations
The Mentholatum Company		002105757	MANUFACTURE(10742-8573)