FDA.reportPublic FDA data

Poolside Frostbite Sunscreen Papaya SPF 15 Scented Lip Gloss

Manufacturer
I World LLC
Effective date
2026-01-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:33:32

Label at a glance#

ProductPoolside Frostbite Sunscreen Papaya SPF 15 Scented Lip Gloss
Active ingredientHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE
Label structure8 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply generously and evenly 15 minutes before sun exposure. Reapply at least every 2 hours Use a water resistant sunscreen if swimming or sweating. Children under 6 month: ask a doctor.

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 5%, Octocrylene 4.5%, Octisalate 4%, Avobenzone 3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

Warnings

WARNINGS SECTION

For external use only.

Skin cancer/skin aging alert

  • Spending time in the sun increases your risk of skin cancer and early skin aging.
  • This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

Do not use

OTC - DO NOT USE SECTION

  • on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes. rinse with water to remove.

Stop use and ask doctor if

OTC - STOP USE SECTION

  • rash occurs.

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 generously and evenly 15 minutes before sun exposure.
  • Reapply at least every 2 hours
  • Use a water resistant sunscreen if swimming or sweating.
  • Children under 6 month: ask a doctor.

Other information

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

POLYISOBUTENE, HYDROGENATED POLYISOBUTENE, VP/HEXADECENE COPOLYMER, OCTYLDODECANOL, MENTHOL, FRAGRANCE, GLYCERYL CAPRYLATE, MENTHOXYPROPANEDIOL, BHT, ALUMINUM HYDROXIDE, WATER, TOCOPHEROL, SODIUM SULFATE, SODIUM CHLORIDE, FD&C YELLOW NO.5 ALUMINUM LAKE (CI 19140).

Questions or comments?

OTC - QUESTIONS SECTION

1-212- 244-5170 info@amora.beauty

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label2Label2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130195207152321GTIN-13: 0195207152321
EAN-13: 0195207152321
GTIN-12: 195207152321
UPC-A: 195207152321
GTIN storage (14 digits): 00195207152321		Label2.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85179-024-00Poolside Frostbite Sunscreen Papaya SPF 15 Scented Lip Gloss15 mL in 1 TUBELIQUID151

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85179-02485179-024-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
TOCOPHEROLR0ZB2556P8IACT
SODIUM SULFATE0YPR65R21JIACT
SODIUM CHLORIDE451W47IQ8XIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
HOMOSALATEV06SV4M95SACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OCTISALATE4X49Y0596WACTIB
AVOBENZONEG63QQF2NOXACTIB
VINYLPYRROLIDONE/HEXADECENE COPOLYMERKFR5QEN0N9IACT
OCTYLDODECANOL461N1O614YIACT
MENTHOLL7T10EIP3AIACT
GLYCERYL MONOCAPRYLATETM2TZD4G4AIACT
3-((L-MENTHYL)OXY)PROPANE-1,2-DIOLKD6TZ2QICHIACT
BUTYLATED HYDROXYTOLUENE1P9D0Z171KIACT
ALUMINUM HYDROXIDE5QB0T2IUN0IACT
WATER059QF0KO0RIACT

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
Poolside Frostbite Sunscreen Papaya SPF 15 Scented Lip GlossHOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONEI World LLC967d0657-18fc-4e4a-b52d-442df43329f12026-01-09WarningsExact identifier
ndc (package): 85179-024-00
ndc (product): 85179-024
ndc11 (package): 85179002400
spl id: 47f88dfb-8960-5699-e063-6394a90aa833
spl set id: 967d0657-18fc-4e4a-b52d-442df43329f1

Reported adverse events (FAERS/openFDA)#

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