pelotan sunscreen broad spectrum spf 30 rollon

pelotan sunscreen broad spectrum spf 30 rollon
SPL v1
SPL
SPL Set ID 3aa0799b-0790-2476-e063-6294a90a8bcc
Route
topical
Published
Effective Date 2025-07-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
octocrylene (100 mg) octinoxate (75 mg) avobenzone (30 mg)
Inactive Ingredients
propylene glycol alpha-tocopherol acetate panthenol aloe vera leaf cyclohexasiloxane c12-15 alkyl benzoate acrylates/octylacrylamide copolymer (40000 mw) benzyl benzoate coumarin alcohol benzyl salicylate cyclopentasiloxane

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2025-07-23

Purpose

Sunscreen

Description

Avobenzone 3% Octinoxate 7.50% Octocrylene 10%


Medication Information

Warnings

For external use only

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

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 of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor
Other Information
  • Protect this product from excessive heat and direct sun
  • Report serious adverse events to Pelotan LLC, 1007 N Orange St. 4th Floor, Wilmington, DE 19801
Inactive Ingredients

Alcohol Denat., C12-15 Alkyl Benzoate, Propylene Glycol, Cyclopentasiloxane, Acrylates/Octylacrylamide Copolymer, Cyclohexasiloxane, Fragrance/Parfum, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Panthenol, Benzyl Benzoate, Benzyl Salicylate, Coumarin

Description

Avobenzone 3% Octinoxate 7.50% Octocrylene 10%

Do Not Use

on damaged or broken skin

Product Label

Active Ingredients

Avobenzone 3%

Octinoxate 7.50%

Octocrylene 10%

Questions Or Comments?

Visit www.pelotan.cc

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.


Structured Label Content

Warnings

For external use only

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

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 of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
  • Children under 6 months: Ask a doctor
Other Information (Other information)
  • Protect this product from excessive heat and direct sun
  • Report serious adverse events to Pelotan LLC, 1007 N Orange St. 4th Floor, Wilmington, DE 19801
Inactive Ingredients (Inactive ingredients)

Alcohol Denat., C12-15 Alkyl Benzoate, Propylene Glycol, Cyclopentasiloxane, Acrylates/Octylacrylamide Copolymer, Cyclohexasiloxane, Fragrance/Parfum, Tocopheryl Acetate, Aloe Barbadensis Leaf Juice, Panthenol, Benzyl Benzoate, Benzyl Salicylate, Coumarin

Do Not Use (Do not use)

on damaged or broken skin

Product Label

Active Ingredients

Avobenzone 3%

Octinoxate 7.50%

Octocrylene 10%

Questions Or Comments? (Questions or comments?)

Visit www.pelotan.cc

When Using This Product (When using this product)

keep out of eyes. Rinse with water to remove.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if rash occurs

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.


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Raw Label Data

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