Drug Facts - Oasis Pineapple Coconut, Peach Mango, Strawberry Kiwi

Drug Facts - Oasis Pineapple Coconut, Peach Mango, Strawberry Kiwi
SPL v3
SPL
SPL Set ID 7c8a4921-ae45-47fb-a64e-c72b1a386d0d
Route
TOPICAL
Published
Effective Date 2019-09-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dimethicone (20 mg) Octinoxate (75 mg) Oxybenzone (40 mg)
Inactive Ingredients
Ceresin Petrolatum Mineral Oil Octyldodecanol Ethylhexyl Palmitate Polyglyceryl-6 Distearate Cetostearyl Alcohol Polyglyceryl-3 Ricinoleate Sodium Chloride Vinylpyrrolidone/eicosene Copolymer Kiwi Fruit Ammonium Glycyrrhizate Pineapple Butylene Glycol Safflower Oil Cetearyl Glucoside Coconut Ethylhexylglycerin Alpine Strawberry Hyaluronic Acid Meadowfoam Seed Oil Mango Racementhol Phymatolithon Calcareum Pentylene Glycol Phenoxyethanol Phytosteryl/octyldodecyl Lauroyl Glutamate Porphyra Umbilicalis Peach Silanetriol Silybum Marianum Seed Oil Tetrahexyldecyl Ascorbate .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-29

Description

Dimethicone 2% Octinoxate 7.5% Oxybenzone 4%

Purpose

Dimethicone - Skin protectant Octinoxate - Sunscreen Oxybenzone – Sunscreen


Medication Information

Purpose

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Oxybenzone – Sunscreen

Description

Dimethicone 2% Octinoxate 7.5% Oxybenzone 4%

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

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
Do Not Use

on damaged or broken skin

Active Ingredient

Dimethicone 2%

Octinoxate 7.5%

Oxybenzone 4%

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

Principal Display Panel
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.

Package/label Principal Display Panel

Structured Label Content

Uses
  • helps prevent sunburn
  • temporarily protects chapped or cracked lips
Purpose

Dimethicone - Skin protectant

Octinoxate - Sunscreen

Oxybenzone – Sunscreen

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

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
Do Not Use (Do not use)

on damaged or broken skin

Active Ingredient (Active ingredient)

Dimethicone 2%

Octinoxate 7.5%

Oxybenzone 4%

Inactive Ingredients (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

Principal Display Panel
When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor If (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.

Package/label Principal Display Panel (Package/Label Principal Display Panel)

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