FDA.reportPublic FDA data

Pelotan Sunscreen Broad Spectrum SPF 30

Manufacturer
Pelotan LLC
Effective date
2025-07-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:08:32

Label at a glance#

ProductPelotan Sunscreen Broad Spectrum SPF 30
Active ingredientOCTOCRYLENE, OCTINOXATE, AVOBENZONE
Label structure9 sections

Indications and 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 and administration

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,...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Octinoxate 7.50%

Octocrylene 10%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • 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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin

Stop use and ask a doctor

OTC - STOP USE SECTION

if rash occurs

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Other information

OTHER SAFETY 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

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85962-002-01Pelotan Sunscreen Broad Spectrum SPF 301 in 1 CARTONSTICK11
85962-002-01Pelotan Sunscreen Broad Spectrum SPF 30177 mL in 1 BOTTLE, WITH APPLICATORSTICK1771

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85962-00285962-002-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
PANTHENOLWV9CM0O67ZIACT
ALOE VERA LEAFZY81Z83H0XIACT
OCTOCRYLENE5A68WGF6WMACTIB
CYCLOHEXASILOXANEXHK3U310BAIACT
OCTINOXATE4Y5P7MUD51ACTIB
C12-15 ALKYL BENZOATEA9EJ3J61HQIACT
ACRYLATES/OCTYLACRYLAMIDE COPOLYMER (40000 MW)7LL6SY9YFVIACT
BENZYL BENZOATEN863NB338GIACT
COUMARINA4VZ22K1WTIACT
ALCOHOL3K9958V90MIACT
BENZYL SALICYLATEWAO5MNK9TUIACT
CYCLOPENTASILOXANE0THT5PCI0RIACT
AVOBENZONEG63QQF2NOXACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pelotan Sunscreen Broad Spectrum SPF 30AVOBENZONE, OCTINOXATE, OCTOCRYLENEPelotan LLC3aa0799b-0790-2476-e063-6294a90a8bcc2025-07-23WarningsExact identifier
ndc (package): 85962-002-01
ndc (product): 85962-002
ndc11 (package): 85962000201
spl id: 3aa05e04-f53f-c339-e063-6394a90a2bdd
spl set id: 3aa0799b-0790-2476-e063-6294a90a8bcc

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.