Pmekr61011r00

Pmekr61011r00
SPL v4
SPL
SPL Set ID 34fae072-536c-ad41-e063-6394a90af0af
Route
TOPICAL
Published
Effective Date 2025-06-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Octisalate (4.5 g) Octocrylene (9 g) Homosalate (13.6 g) Avobenzone (2.7 g)
Inactive Ingredients
Water Butyloctyl Salicylate Caprylyl Methicone 1,2-hexanediol Propanediol

Identifiers & Packaging

Pill Appearance
Color: pink
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-01

Description

Directions • Apply liberally and evenly 15 minutes before sun exposure. • Children under 6 months of age: Ask a doctor. • Reapply at least every 2 hours. • Use a water resistant sunscreen if swimming or sweating. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses.

Indications and Usage

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

Purpose

Sunscreen


Medication Information

Indications and Usage

Uses

• Helps prevent sunburn.

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

Purpose

Sunscreen

Description

Directions • Apply liberally and evenly 15 minutes before sun exposure. • Children under 6 months of age: Ask a doctor. • Reapply at least every 2 hours. • Use a water resistant sunscreen if swimming or sweating. Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: • limit time in the sun, especially from 10 a.m.-2 p.m. • wear long-sleeved shirts, pants, hats, and sunglasses.

Warnings
  • 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.
  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away
Inactive Ingredients

WATER, BUTYLOCTYL SALICYLATE, PROPANEDIOL, SILICA, 1,2-HEXANEDIOL, CAPRYLYL METHICONE, PENTYLENE GLYCOL, POLYGLYCERYL-3 DISTEARATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, CETEARYL ALCOHOL, POLY C10-30 ALKYL ACRYLATE, TROMETHAMINE, POLYACRYLATE CROSSPOLYMER-6, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, SODIUM STEAROYL GLUTAMATE, BUTYLENE GLYCOL, GLYCERYL STEARATE CITRATE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, XANTHAN GUM, ETHYLHEXYLGLYCERIN, CYANOCOBALAMIN, NIACINAMIDE, CERAMIDE NP, SQUALANE, TOCOPHEROL, HYDROLYZED COLLAGEN, ASIATICOSIDE, MADECASSIC ACID, ASIATIC ACID, CENTELLA ASIATICA EXTRACT, HYALURONIC ACID, CAPRYLYL GLYCOL, SOLUBLE COLLAGEN, ACETYL HEXAPEPTIDE-8

Dosage & Administration

Directions

• Apply liberally and evenly 15 minutes before sun exposure.

• Children under 6 months of age: Ask a doctor.

• Reapply at least every 2 hours.

• Use a water resistant sunscreen if swimming or sweating.

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m.-2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses.

Principal Display Panel

Keep Out of Reach of Children

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


Structured Label Content

Purpose

Sunscreen

Warnings
  • 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.
  • Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away
Inactive Ingredients

WATER, BUTYLOCTYL SALICYLATE, PROPANEDIOL, SILICA, 1,2-HEXANEDIOL, CAPRYLYL METHICONE, PENTYLENE GLYCOL, POLYGLYCERYL-3 DISTEARATE, DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER, CETEARYL ALCOHOL, POLY C10-30 ALKYL ACRYLATE, TROMETHAMINE, POLYACRYLATE CROSSPOLYMER-6, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, SODIUM STEAROYL GLUTAMATE, BUTYLENE GLYCOL, GLYCERYL STEARATE CITRATE, AMMONIUM ACRYLOYLDIMETHYLTAURATE/VP COPOLYMER, XANTHAN GUM, ETHYLHEXYLGLYCERIN, CYANOCOBALAMIN, NIACINAMIDE, CERAMIDE NP, SQUALANE, TOCOPHEROL, HYDROLYZED COLLAGEN, ASIATICOSIDE, MADECASSIC ACID, ASIATIC ACID, CENTELLA ASIATICA EXTRACT, HYALURONIC ACID, CAPRYLYL GLYCOL, SOLUBLE COLLAGEN, ACETYL HEXAPEPTIDE-8

Indications and Usage

Uses

• Helps prevent sunburn.

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

Dosage & Administration (DOSAGE & ADMINISTRATION)

Directions

• Apply liberally and evenly 15 minutes before sun exposure.

• Children under 6 months of age: Ask a doctor.

• Reapply at least every 2 hours.

• Use a water resistant sunscreen if swimming or sweating.

Sun Protection Measures: Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

• limit time in the sun, especially from 10 a.m.-2 p.m.

• wear long-sleeved shirts, pants, hats, and sunglasses.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep out of reach of children)

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


Advanced Ingredient Data


Raw Label Data

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