SOFTLIPS SALTED CARAMEL, CANDY APPLE, MARSHMALLOW GHOST- dimethicone, octinoxate, octisalate, oxybenzone stick

Softlips Salted Caramel, Candy Apple, Marshmallow Ghost by

Drug Labeling and Warnings

Softlips Salted Caramel, Candy Apple, Marshmallow Ghost by is a Otc medication manufactured, distributed, or labeled by The Mentholatum Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Dimethicone 2%

Octinoxate 7.5%

Octisalate 3%

Oxybenzone 3%

Purpose

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Octisalate - Sunscreen

Oxybenzone - Sunscreen

Keep Out of Reach of Children

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

Uses

• helps prevent sunburn
• temporarily protects chapped or cracked lips

Warnings

Skin Cancer/Skin Aging Alert: Spending time in the sun increased 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

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

Inactive ingredients

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

Package/Label Principal Display Panel

Principal Display Panel

INGREDIENTS AND APPEARANCE

SOFTLIPS SALTED CARAMEL, CANDY APPLE, MARSHMALLOW GHOST 
dimethicone, octinoxate, octisalate, oxybenzone stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10742-7004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O)	DIMETHICONE	20 mg  in 1 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	75 mg  in 1 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 mg  in 1 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	30 ug  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CERESIN (UNII: Q1LS2UJO3A)
SQUALANE (UNII: GW89575KF9)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
PETROLATUM (UNII: 4T6H12BN9U)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
MYRISTYL LACTATE (UNII: 1D822OC34X)
CETYL ALCOHOL (UNII: 936JST6JCN)
MYRISTYL LAURATE (UNII: 58U0NZN2BT)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10742-7004-3	3 in 1 BLISTER PACK	10/15/2018
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	10/15/2018

Labeler - The Mentholatum Company (002105757)

Registrant - The Mentholatum Company (002105757)

Establishment
Name	Address	ID/FEI	Business Operations
The Mentholatum Company		002105757	MANUFACTURE(10742-7004)