SOFTLIPS CUBE STRAWBERRY- dimethicone, octinoxate, oxybenzone ointment
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.

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Drug Facts

Active ingredients

Dimethicone 2%

Octinoxate 7.5%

Oxybenzone 3%

Purpose

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Oxybenzone - Sunscreen

Uses

•: helps prevent sunburn
•: temporarily protects chapped or cracked lips

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
•: 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.

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

ozokerite, petrolatum, octyldodecyl olivate, ethylhexyl palmitate, octyldodecanol, myristyl myristate, myristyl lactate, squalane, brassica campestris/aleurites fordi oil copolymer, cetyl alcohol, flavor, butyrospermum parkii (shea) butter, stearyl olivate, myristyl laurate, myristyl alcohol, BHT, helianthus annuus (sunflower) seed oil, linoleic acid, linolenic acid, menthol, neopentyl glycol dicaprylate/dicaprate, PEG-8, retinyl palmitate, sodium saccharin, tetrahexyldecyl ascorbate [Vitamin C], tocopherol [Vitamin E], tocopheryl acetate [Vitamin E]

Questions?

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

Package/Label Principal Display Panel

Package/Label Principal Display Panel

SOFTLIPS CUBE STRAWBERRY
dimethicone, octinoxate, oxybenzone ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:10742-8682
Route of Administration	TOPICAL

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

Ingredient Name	Strength
Inactive Ingredients
CERESIN (UNII: Q1LS2UJO3A)
PETROLATUM (UNII: 4T6H12BN9U)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
OCTYLDODECANOL (UNII: 461N1O614Y)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
MYRISTYL LACTATE (UNII: 1D822OC34X)
SQUALANE (UNII: GW89575KF9)
CETYL ALCOHOL (UNII: 936JST6JCN)
SHEA BUTTER (UNII: K49155WL9Y)
MYRISTYL LAURATE (UNII: 58U0NZN2BT)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
SUNFLOWER OIL (UNII: 3W1JG795YI)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
LINOLENIC ACID (UNII: 0RBV727H71)
MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)
NEOPENTYL GLYCOL DICAPRYLATE/DICAPRATE (UNII: VLW429K27K)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TOCOPHEROL (UNII: R0ZB2556P8)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:10742-8682-1	1 in 1 BLISTER PACK	09/01/2014	11/23/2018
1		6.5 g in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	09/01/2014	11/23/2018

Labeler - The Mentholatum Company (002105757)

Revised: 1/2018

Document Id: 27cec66d-87e7-44ae-8ea0-fc73187a9f0e

Set id: 21c13111-d2a3-41f2-ac1a-5d2aa57c4a66

Version: 3

Effective Time: 20180115

The Mentholatum Company