FDA.reportPublic FDA data

Oars & Alps SPF 30 Hydrating Antioxidant Sunscreen Spray

Manufacturer
Oars and Alps LLC
Effective date
2022-11-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:49:05

Label at a glance#

ProductOars and Alps SPF 30 Hydrating Antioxidant Sunscreen
Active ingredientAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE
Label structure10 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 generously and evenly 15 minutes before sun exposure Hold container 4-6 inches from the skin to apply Do not spray directly onto the face. Spray onto hands and rub onto face. Do not inhale. Do not apply in windy conditions. Use in well ventilated area. Reapply: After 80 minutes of swimming or sweating, immedately after towl drying, at least every 2 hours. Sun Protection Measures: Spending time in the sun inc...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Avobenzone - 2.4%

Homosalate - 9.8%

Octisalate - 4.9%

Octocrylene - 9.5%

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 SECTION

  • For external use only.
  • Flammable. Contents under pressure. Keep away from fire, smoke, other sources of ignition or while smoking. Do not puncture of incinerate can. Do not store above 120 F.
  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply generously and evenly 15 minutes before sun exposure
  • Hold container 4-6 inches from the skin to apply
  • Do not spray directly onto the face. Spray onto hands and rub onto face. Do not inhale.
  • Do not apply in windy conditions.
  • Use in well ventilated area.
  • Reapply: After 80 minutes of swimming or sweating, immedately after towl 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 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.​
  • Children under six months: Ask a doctor.

INACTIVE INGREDIENT SECTION

Alcohol Denat., Butyloctyl Salicylate, Citrus Paradisi (Grapefruit) Peel Oil, Cladonia Stellaris Extract, Dicaprylyl Carbonate, Diisopropyl Adipate, Ethyl Ferulate, Ethyl Olivate, Fragrance, Helianthus Annuus (Sunflower) Seed Oil, Isocetyl Stearoyl Stearate, Isodecyl Neopentanoate, Olea Europaea (Olive) Leaf Extract, Tetrahexyldecyl Ascorbate, Tridecyl Neopentanoate, VA/Butyl Maleate/Isobornyl Acrylate Copolymer

OTHER SAFETY INFORMATION

  • Protect the product in this container from excessive heat and direct sun
  • Avoid spraying on facbrics - may cause discoloration

OTC - QUESTIONS SECTION

Contact Hi@oarsandalps.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83046-36583046-365-13

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
BUTYLOCTYL SALICYLATE2EH13UN8D3IACT
ETHYL OLIVATEKKJ108Y20WIACT
ISOCETYL STEAROYL STEARATEIJV4LS383RIACT
ISODECYL NEOPENTANOATEW60VYE24XCIACT
OLEA EUROPAEA LEAFMJ95C3OH47IACT
TETRAHEXYLDECYL ASCORBATE9LBV3F07AZIACT
TRIDECYL NEOPENTANOATE3Z8H1DA7J5IACT
VINYL ACETATEL9MK238N77IACT
ALCOHOL3K9958V90MIACT
ETHYL FERULATE5B8915UELWIACT
GRAPEFRUIT OILYR377U58W9IACT
CLADONIA RANGIFERINA WHOLEO21ZF987XQIACT
DICAPRYLYL CARBONATE609A3V1SUAIACT
DIISOPROPYL ADIPATEP7E6YFV72XIACT
SUNFLOWER OIL3W1JG795YIIACT
DIBUTYL MALEATE4X371TMK9KIACT
ISOBORNYL ACRYLATEIX0PRH184PIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB

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
ed10edf1-c553-b416-e053-2995a90adbf8ed10edf1-c552-b416-e053-2995a90adbf82022-11-09WarningsExact identifier
spl id: ed10edf1-c553-b416-e053-2995a90adbf8
spl set id: ed10edf1-c552-b416-e053-2995a90adbf8

Reported adverse events (FAERS/openFDA)#

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