FDA.reportPublic FDA data

Poolside Frostbite Sunscreen Papaya SPF 15 Scented Lip Gloss

Product NDC
85179-024
11-digit product format
851790024
Labeler code
85179
Product ID
85179-024_47f88dfb-8960-5699-e063-6394a90aa833
Type
HUMAN OTC DRUG
Nonproprietary name
HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE
Dosage form
LIQUID
Route
TOPICAL
Labeler
I World LLC
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-17
Substance
HOMOSALATE; OCTOCRYLENE; OCTISALATE; AVOBENZONE
Active strength
50; 45; 40; 30 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Poolside Frostbite Sunscreen Papaya SPF 15 Scented Lip Gloss
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE50 mg/mL
OCTOCRYLENE45 mg/mL
OCTISALATE40 mg/mL
AVOBENZONE30 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V06SV4M95SInternal UNII lookup
5A68WGF6WMInternal UNII lookup
4X49Y0596WInternal UNII lookup
G63QQF2NOXInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
967d0657-18fc-4e4a-b52d-442df43329f1Available on FDA.report

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

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 257 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CLE CCC Neutral Medium LightTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.615f5e39-695d-41d4-af59-e0d3b76789bb2024-12-19WarningsExact identifier
application number: M020
CLE CCC Warm DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATE, AVOBENZONEKW ABSC, INC.6ab3e360-8104-4439-93fb-e11bc4a775582024-12-19WarningsExact identifier
application number: M020
CLE CCC Neutral MediumTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.a297ff64-678c-4936-8384-022606a2f33c2024-12-19WarningsExact identifier
application number: M020
CLE CCC Neutral FairTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.aa8176c6-f1c9-43dd-96e0-f7d6ed30a1a22024-12-19WarningsExact identifier
application number: M020
CLE CCC Cool Medium DeepTITANIUM DIOXIDE, OCTINOXATE, OCTISALATEKW ABSC, INC.2e0365f9-d3c6-4404-90ac-772a829b3ade2024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18- D2 NUTMEGOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29abae8f-53db-b592-e063-6294a90adabb2024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 MOCHAOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29aba80c-55b7-b8d9-e063-6294a90a5cc12024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 COCOAOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29abe97b-e9b3-6e27-e063-6294a90ae3ed2024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 DEEP GOLDENOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29abdf3c-fb54-a5e3-e063-6394a90af4502024-12-19WarningsExact identifier
application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM FAIRZINC OXIDECOSMAX USA, CORPORATION29ac756b-3df7-50c9-e063-6394a90aa4792024-12-19WarningsExact identifier
application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM RICHZINC OXIDECOSMAX USA, CORPORATION29ac51a0-07e7-ad7b-e063-6294a90ae7772024-12-19WarningsExact identifier
application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM DEEPESTZINC OXIDECOSMAX USA, CORPORATION29ad12e2-0a2e-7138-e063-6394a90aebaf2024-12-19WarningsExact identifier
application number: M020
CeraVe Developed with Dermatologists Hydrating Mineral Sunscreen Broad Spectrum SPF 30 Face Sheer Tint SunscreenTITANIUM DIOXIDE AND ZINC OXIDEL'Oreal USA Products, Inc.f2e34230-7bfb-455f-8b33-6bff96fd9f0a2024-12-19WarningsExact identifier
application number: M020
Anew Platinum DayCream Broad Spectrum SPF 25AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONECOSMAX USA, CORPORATION56200212-bedc-6e1e-e063-6394a90a36662024-12-19WarningsExact identifier
application number: M020
Light Illusion Luminous Makeup Nude-Skin Feel SPF18 SHELLOCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDECOSMAX USA, INC29868d60-b900-e0ad-e063-6294a90af87a2024-12-18WarningsExact identifier
application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM MEDIUMZINC OXIDECOSMAX USA, CORPORATION298707d4-72ed-796f-e063-6294a90aa5cd2024-12-18WarningsExact identifier
application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM LIGHTZINC OXIDECOSMAX USA, CORPORATION29871c02-9adf-6266-e063-6394a90a20ab2024-12-18WarningsExact identifier
application number: M020
MILK TINT SPF 43 TINTED PRIMER SERUM TANZINC OXIDECOSMAX USA, CORPORATION29874029-24bf-b2ce-e063-6394a90acd4d2024-12-18WarningsExact identifier
application number: M020
Babo Botanicals Sheer Zinc Mineral Sunscreen SPF 30ZINC OXIDEBabo Botanicals, Inc.2990e4ff-5bdb-3008-e063-6294a90a94972024-12-18WarningsExact identifier
application number: M020
Tinted Lip Cream SPF 15ZINC OXIDECOSMAX USA, CORPORATION29915354-4673-7444-e063-6294a90a0fd12024-12-18WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85179-024-008517900240015 mL in 1 TUBE (85179-024-00) 15 ml2025-12-17NoNoCurrent