Burnd Spf 41 Sunscreen

Burnd Spf 41 Sunscreen
SPL v5
SPL
SPL Set ID 31cf923e-fdde-790b-e063-6294a90a60ee
Route
TOPICAL
Published
Effective Date 2025-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Homosalate (8 g) Octinoxate (7.5 g) Zinc Oxide (8.1 g)
Inactive Ingredients
Triethoxycaprylylsilane Hydrogenated Castor Oil Water Diethylhexyl Sebacate Aluminum Starch Octenylsuccinate Bis-peg-12 Dimethicone (70 Mpa.s) Ethylhexylglycerin Silicon Dioxide Sodium Chloride Peg-30 Dipolyhydroxystearate .alpha.-tocopherol Acetate Peg/ppg-20/15 Dimethicone Dimethicone/vinyl Dimethicone Crosspolymer (soft Particle) Ascorbyl Palmitate Caprylhydroxamic Acid Methylpropanediol Cyclopentasiloxane Propanediol Caprylyl Glycol Decyl Glucoside

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-09

Description

Homosalate 8.0 % Octinoxate 7.5% Zinc Oxide 8.1%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Homosalate 8.0 % Octinoxate 7.5% Zinc Oxide 8.1%

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
Section 51945-4

Warnings:

For external use only.

Do not useon damaged or broken skin.

When using this product, keep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif rash occurs.

Directions:

Apply liberally 15 minutes before sun exposure.



• REAPPLY: • After 80 minutes of swimming or sweating.

• Immediately after towel drying. • At least every 2 hours.

SUN PROTECTION MEASURES: Spending time in the sun increases your risk ofskin 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. to 2 p.m.
  • Wear long-sleeved shirts, pants, hats and sunglasses.
  • Children under 6 months of age: Ask a doctor.

Active Ingredients

Homosalate 8.0 %

Octinoxate 7.5%

Zinc Oxide 8.1%

Other Information:
  • Protect the product in this container from excessive heat and direct sun.
  • May stain some fabrics.
Inactive Ingredients:

Aluminum Starch Octenylsuccinate,Ascorbyl Palmitate, Bis-PEG-12 Dimethicone Beeswax,Caprylhydroxamic Acid, Caprylyl Glycol, Cyclopentasiloxane,Decyl Glucoside, Diethylhexyl Sebacate, Ethylhexylglycerin,Hydrogenated Castor Oil, Methylpropanediol, PEG/PPG-20/15 Dimethicone, PEG-30 Dipolyhydroxystearate,Polysilicone-11, Propanediol, Silica, Sodium Chloride,Tocopheryl Acetate, Triethoxycaprylylsilane, Water (Aqua)

Keep Out of Reach of Children

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


Structured Label Content

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
Section 51945-4 (51945-4)

Purpose

Sunscreen

Warnings:

For external use only.

Do not useon damaged or broken skin.

When using this product, keep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif rash occurs.

Directions:

Apply liberally 15 minutes before sun exposure.



• REAPPLY: • After 80 minutes of swimming or sweating.

• Immediately after towel drying. • At least every 2 hours.

SUN PROTECTION MEASURES: Spending time in the sun increases your risk ofskin 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. to 2 p.m.
  • Wear long-sleeved shirts, pants, hats and sunglasses.
  • Children under 6 months of age: Ask a doctor.

Active Ingredients

Homosalate 8.0 %

Octinoxate 7.5%

Zinc Oxide 8.1%

Other Information:
  • Protect the product in this container from excessive heat and direct sun.
  • May stain some fabrics.
Inactive Ingredients:

Aluminum Starch Octenylsuccinate,Ascorbyl Palmitate, Bis-PEG-12 Dimethicone Beeswax,Caprylhydroxamic Acid, Caprylyl Glycol, Cyclopentasiloxane,Decyl Glucoside, Diethylhexyl Sebacate, Ethylhexylglycerin,Hydrogenated Castor Oil, Methylpropanediol, PEG/PPG-20/15 Dimethicone, PEG-30 Dipolyhydroxystearate,Polysilicone-11, Propanediol, Silica, Sodium Chloride,Tocopheryl Acetate, Triethoxycaprylylsilane, Water (Aqua)

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

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


Advanced Ingredient Data


Raw Label Data

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