SOFTLIPS OASIS PINEAPPLE COCONUT, PEACH MANGO, STRAWBERRY KIWI- dimethicone, oxybenzone, octinoxate stick

Softlips by

Drug Labeling and Warnings

Softlips 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%

Oxybenzone 4%

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

Pineapple Coconut: ozokerite, petrolatum, mineral oil, octyldodecanol, ethylhexyl palmitate, polyglyceryl-6 octastearate, cetearyl alcohol, flavor, polyglyceryl-6 polyricinoleate, sea water, VP/eicosene copolymer, ammonium glycyrrhizate, ananas sativus (pineapple) fruit extract, butylene glycol, carthamus tinctorius (safflower) seed oil, cetearyl glucoside, cocos nucifera (coconut) extract, ethylhexylglycerin, hyaluronic acid, limnanthes alba (meadowfoam) seed oil, menthol, nannochloropsis oculata extract, pentylene glycol, phenoxyethanol, phytosteryl/octyldodecyl lauroyl glutamate, porphyra umbilicalis extract, silanetriol, silybum marianum seed oil, tetrahexyldecyl ascorbate [vitamin C], tocopheryl acetate [vitamin E]

Peach Mango: ozokerite, petrolatum, mineral oil, octyldodecanol, ethylhexyl palmitate, polyglyceryl-6 octastearate, cetearyl alcohol, flavor, polyglyceryl-6 polyricinoleate, sea water, VP/eicosene copolymer, ammonium glycyrrhizate, butylene glycol, carthamus tinctorius (safflower) seed oil, cetearyl glucoside, ethylhexylglycerin, hyaluronic acid, limnanthes alba (meadowfoam) seed oil, mangifera indica (mango) fruit extract, menthol, nannochloropsis oculata extract, pentylene glycol, phenoxyethanol, phytosteryl/octyldodecyl lauroyl glutamate, porphyra umbilicalis extract, prunus persica (peach) fruit extract, silanetriol, silybum marianum seed oil, tetrahexyldecyl ascorbate [vitamin C], tocopheryl acetate [vitamin E]

Strawberry Kiwi: ozokerite, petrolatum, mineral oil, octyldodecanol, ethylhexyl palmitate, polyglyceryl-6 octastearate, cetearyl alcohol, flavor, polyglyceryl-6 polyricinoleate, sea water, VP/eicosene copolymer, actinidia chinesis (kiwi) fruit extract, ammonium glycyrrhizate, butylene glycol, carthamus tinctorius (safflower) seed oil, cetearyl glucoside, ethylhexylglycerin, fragaria vesca (strawberry) fruit extract, hyaluronic acid, limnanthes alba (meadowfoam) seed oil, menthol, nannochloropsis oculata extract, pentylene glycol, phenoxyethanol, phytosteryl/octyldodecyl lauroyl glutamate, porphyra umbilicalis extract, silanetriol, silybum marianum seed oil, tetrahexyldecyl ascorbate [vitamin C], tocopheryl acetate [vitamin E]

Questions? 1-877-636-2677

MON-FRI 9 AM to 5 PM (EST) softlips.com

Package/Label Principal Display Panel

Principal Display Panel

INGREDIENTS AND APPEARANCE

SOFTLIPS  OASIS PINEAPPLE COCONUT, PEACH MANGO, STRAWBERRY KIWI
dimethicone, oxybenzone, octinoxate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 10742-8744
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
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	40 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CERESIN (UNII: Q1LS2UJO3A)
PETROLATUM (UNII: 4T6H12BN9U)
MINERAL OIL (UNII: T5L8T28FGP)
OCTYLDODECANOL (UNII: 461N1O614Y)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
POLYGLYCERYL-6 DISTEARATE (UNII: Z35I17EQOP)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
POLYGLYCERYL-3 RICINOLEATE (UNII: MZQ63P0N0W)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
VINYLPYRROLIDONE/EICOSENE COPOLYMER (UNII: 035MV9S1C3)
KIWI FRUIT (UNII: 71ES77LGJC)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
PINEAPPLE (UNII: 2A88ZO081O)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
SAFFLOWER OIL (UNII: 65UEH262IS)
CETEARYL GLUCOSIDE (UNII: 09FUA47KNA)
COCONUT (UNII: 3RT3536DHY)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
ALPINE STRAWBERRY (UNII: CG6IX3GCMU)
HYALURONIC ACID (UNII: S270N0TRQY)
MEADOWFOAM SEED OIL (UNII: 412ZHA4T4Y)
MANGO (UNII: I629I3NR86)
RACEMENTHOL (UNII: YS08XHA860)
PHYMATOLITHON CALCAREUM (UNII: 6J1M3WA0ZK)
PENTYLENE GLYCOL (UNII: 50C1307PZG)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHYTOSTERYL/OCTYLDODECYL LAUROYL GLUTAMATE (UNII: 65954KGO9Q)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)
PEACH (UNII: 3OKE88I3QG)
SILANETRIOL (UNII: E52D0J3TS5)
SILYBUM MARIANUM SEED OIL (UNII: NYY23HEN06)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 10742-8744-1	6 in 1 POUCH	10/01/2019
1		4.5 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 not final	part352	07/29/2019

Labeler - The Mentholatum Company (002105757)

Registrant - The Mentholatum Company (002105757)

Establishment
Name	Address	ID/FEI	Business Operations
The Mentholatum Company		002105757	MANUFACTURE(10742-8744)