Drug Facts - Softlips Oasis Watermelon Blackberry

Drug Facts - Softlips Oasis Watermelon Blackberry
SPL v3
SPL
SPL Set ID e1213808-4dad-4fd0-871a-04bba094a3cc
Route
TOPICAL
Published
Effective Date 2019-01-02
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 Ammonium Glycyrrhizate Butylene Glycol Safflower Oil Cetearyl Glucoside Watermelon Ethylhexylglycerin Hyaluronic Acid Meadowfoam Seed Oil Menthol, Unspecified Form Phymatolithon Calcareum Pentylene Glycol Phenoxyethanol Phytosteryl/octyldodecyl Lauroyl Glutamate Porphyra Umbilicalis Blackberry Sodium Chloride Silanetriol Silybum Marianum Seed Oil Tetrahexyldecyl Ascorbate .alpha.-tocopherol Acetate Eicosyl Povidone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-05-01
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
Do Not Use

on damaged or broken skin

Active Ingredient

Dimethicone 2%

Octinoxate 7.5%

Oxybenzone 4%

Inactive Ingredients

ozokerite, petrolatum, mineral oil, octyldodecanol, ethylhexyl palmitate, flavor, polyglyceryl-6 octastearate, cetearyl alcohol, polyglyceryl-6 polyricinoleate, ammonium glycyrrhizate, butylene glycol, carthamus tinctorius (safflower) seed oil, cetearyl glucoside, citrullus lanatus (watermelon) fruit extract, ethylhexylglycerin, hyaluronic acid, limnanthes alba (meadowfoam) seed oil, menthol, nannochloropsis oculata extract, pentylene glycol, phenoxyethanol, phytosteryl/octyldodecyl lauroyl glutamate, porphyra umbilicalis extract, rubus fruticosus (blackberry) fruit extract, sea water, silanetriol, silybum marianum seed oil, tetrahexyldecyl ascorbate, tocopheryl acetate, VP/eicosene copolymer

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
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)

ozokerite, petrolatum, mineral oil, octyldodecanol, ethylhexyl palmitate, flavor, polyglyceryl-6 octastearate, cetearyl alcohol, polyglyceryl-6 polyricinoleate, ammonium glycyrrhizate, butylene glycol, carthamus tinctorius (safflower) seed oil, cetearyl glucoside, citrullus lanatus (watermelon) fruit extract, ethylhexylglycerin, hyaluronic acid, limnanthes alba (meadowfoam) seed oil, menthol, nannochloropsis oculata extract, pentylene glycol, phenoxyethanol, phytosteryl/octyldodecyl lauroyl glutamate, porphyra umbilicalis extract, rubus fruticosus (blackberry) fruit extract, sea water, silanetriol, silybum marianum seed oil, tetrahexyldecyl ascorbate, tocopheryl acetate, VP/eicosene copolymer

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)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:52.719234 · Updated: 2026-03-14T23:05:59.331876