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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O), OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51), OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)
Available from:
The Mentholatum Company
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Dimethicone - Skin protectant Octinoxate - Sunscreen Oxybenzone – Sunscreen
Authorization status:
OTC monograph not final
Authorization number:
10742-8744-1

SOFTLIPS OASIS PINEAPPLE COCONUT, PEACH MANGO, STRAWBERRY KIWI-

dimethicone, oxybenzone, octinoxate stick

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.

----------

Drug Facts

Active ingredient

Dimethicone 2%

Octinoxate 7.5%

Oxybenzone 4%

Purpos e

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Oxybenzone – Sunscreen

Us es

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

Keep Out of Reach of Children

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

helps prevent sunburn

temporarily protects chapped or cracked lips

rash occurs

condition worsens

symptoms last more than 7 days or clear up and occur again within a few days

Directions

Other information

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

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

protect this product from excessive heat and direct sun

Principal Display Panel

SOFTLIPS OASIS PINEAPPLE COCONUT, PEACH MANGO, STRAWBERRY

KIWI

dimethicone, oxybenzone, octinoxate stick

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:10 742-8 744

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

DIMETHICO NE (UNII: 9 2RU3N3Y1O) (DIMETHICONE - UNII:9 2RU3N3Y1O)

DIMETHICONE

20 mg in 1 g

O CTINO XATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)

OCTINOXATE

75 mg in 1 g

O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y)

OXYBENZONE

40 mg in 1 g

Inactive Ingredients

Ingredient Name

Stre ng th

CERESIN (UNII: Q1LS2UJO3A)

PETRO LATUM (UNII: 4T6 H12BN9 U)

MINERAL O IL (UNII: T5L8 T28 FGP)

O CTYLDO DECANO L (UNII: 46 1N1O6 14Y)

ETHYLHEXYL PALMITATE (UNII: 28 6 59 9 330 9 )

PO LYGLYCERYL-6 DISTEARATE (UNII: Z35I17EQOP)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

PO LYGLYCERYL-3 RICINO LEATE (UNII: MZQ6 3P0 N0 W)

SO DIUM CHLO RIDE (UNII: 451W47IQ8 X)

VINYLPYRRO LIDO NE/EICO SENE CO PO LYMER (UNII: 0 35MV9 S1C3)

KIWI FRUIT (UNII: 71ES77LGJC)

AMMO NIUM GLYCYRRHIZATE (UNII: 3VRD35U26 C)

PINEAPPLE (UNII: 2A8 8 ZO0 8 1O)

BUTYLENE GLYCO L (UNII: 3XUS8 5K0 RA)

SAFFLO WER O IL (UNII: 6 5UEH26 2IS)

CETEARYL GLUCO SIDE (UNII: 0 9 FUA47KNA)

CO CO NUT (UNII: 3RT3536 DHY)

ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)

ALPINE STRAWBERRY (UNII: CG6 IX3GCMU)

HYALURO NIC ACID (UNII: S270 N0 TRQY)

MEADO WFO AM SEED O IL (UNII: 412ZHA4T4Y)

MANGO (UNII: I6 29 I3NR8 6 )

RACEMENTHO L (UNII: YS0 8 XHA8 6 0 )

PHYMATO LITHO N CALCAREUM (UNII: 6 J1M3WA0 ZK)

PENTYLENE GLYCO L (UNII: 50 C130 7PZG)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PHYTO STERYL/O CTYLDO DECYL LAURO YL GLUTAMATE (UNII: 6 59 54KGO9 Q)

PO RPHYRA UMBILICALIS (UNII: 14AN0 J70 WO)

PEACH (UNII: 3OKE8 8 I3QG)

SILANETRIO L (UNII: E52D0 J3TS5)

SILYBUM MARIANUM SEED O IL (UNII: NYY23HEN0 6 )

TETRAHEXYLDECYL ASCO RBATE (UNII: 9 LBV3F0 7AZ)

.ALPHA.-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:10 742-8 744-1

6 in 1 POUCH

10 /0 1/20 19

1

4.5 g in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

The Mentholatum Company

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 7/29 /20 19

Labeler -

T he Mentholatum Company (002105757)

Registrant -

T he Mentholatum Company (002105757)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

The Mentho latum Co mpany

0 0 210 5757

MANUFACTURE(10 742-8 744)

Revised: 9/2019

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