81417-009 my medic sunscreen spf30

81417-009 my medic sunscreen spf30
SPL v2
SPL
SPL Set ID ec252876-7205-83ec-e053-2a95a90a1463
Route
topical
Published
Effective Date 2022-10-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
ensulizole (1.5 g) octisalate (4.5 g) homosalate (14 g) titanium dioxide (10 g)
Inactive Ingredients
glyceryl caprylate glyceryl monostearate butyloctyl salicylate glycerin dimethicone peg-100 stearate aluminum hydroxide xanthan gum levomenol potassium cetyl phosphate caprylhydroxamic acid water ammonium acryloyldimethyltaurate, dimethylacrylamide, lauryl methacrylate and laureth-4 methacrylate copolymer, trimethylolpropane triacrylate crosslinked (45000 mpa.s) stearic acid isohexadecane polyhydroxystearic acid stearate 1,2-hexanediol vinylpyrrolidone/eicosene copolymer trolamine propylene glycol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-10-31
Purpose

Sunscreen

Description

Homosalate 14% Titanium Dioxide 10% Ethylhexyl Salicylate 4.5% Phenylbenzimidazole Sulfonic Acid 1.5%

Medication Information

Warnings
  • For external use only
Uses

Helps prevent sunburn.

lf used as directed with other sunburn protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Purpose

Sunscreen

Directions
  • Apply to skin liberally, avoiding the eye area.
  • Wait at least 30 mins before sun exposure, or as directed by a physician.
  • Re-apply after 80 mniutes of swimming and/or sweating.
  • Re-apply immediately after towel drying and at least every 3 hours.
Inactive Ingredients

Aluminum Hydroxide, Bisabolol, Butyloctyl Salicylate, Caprylhydroxamic Acid, Dimethicone, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, lsohexadecane, Peg-100 Stearate, Polyacrylate Crosspolymer-6, Polyhydroxystearic Acid, Potassium Cetyl Phosphate, Propylene Glycol, Stearic Acid, Triethanolamine, VP Eicosene Copolymer, Water, Xanthan Gum, 1,2 Hexanediol

Description

Homosalate 14% Titanium Dioxide 10% Ethylhexyl Salicylate 4.5% Phenylbenzimidazole Sulfonic Acid 1.5%

Section 50565-1
  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Section 50567-7
  • When using this product keep out of eyes.

Rinse with water to remove.

Section 50569-3
  • Stop use and ask a doctor if rash occurs
Section 50570-1
  • Do not use on damaged or broken skin
Section 51945-4

Active Ingredient

Homosalate 14%

Titanium Dioxide 10%

Ethylhexyl Salicylate 4.5%

Phenylbenzimidazole Sulfonic Acid 1.5%

Structured Label Content

Warnings
  • For external use only
Uses

Helps prevent sunburn.

lf used as directed with other sunburn protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Purpose

Sunscreen

Directions
  • Apply to skin liberally, avoiding the eye area.
  • Wait at least 30 mins before sun exposure, or as directed by a physician.
  • Re-apply after 80 mniutes of swimming and/or sweating.
  • Re-apply immediately after towel drying and at least every 3 hours.
Inactive Ingredients (Inactive ingredients)

Aluminum Hydroxide, Bisabolol, Butyloctyl Salicylate, Caprylhydroxamic Acid, Dimethicone, Glycerin, Glyceryl Caprylate, Glyceryl Stearate, lsohexadecane, Peg-100 Stearate, Polyacrylate Crosspolymer-6, Polyhydroxystearic Acid, Potassium Cetyl Phosphate, Propylene Glycol, Stearic Acid, Triethanolamine, VP Eicosene Copolymer, Water, Xanthan Gum, 1,2 Hexanediol

Section 50565-1 (50565-1)
  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.
Section 50567-7 (50567-7)
  • When using this product keep out of eyes.

Rinse with water to remove.

Section 50569-3 (50569-3)
  • Stop use and ask a doctor if rash occurs
Section 50570-1 (50570-1)
  • Do not use on damaged or broken skin
Section 51945-4 (51945-4)

Active Ingredient (Active ingredient)

Homosalate 14%

Titanium Dioxide 10%

Ethylhexyl Salicylate 4.5%

Phenylbenzimidazole Sulfonic Acid 1.5%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:42.466090 · Updated: 2026-03-14T23:02:24.469183