FDA.reportPublic FDA data

Poolside Frostbite Sunscreen Papaya SPF 15 Scented lip gloss

Product NDC
85161-159
Requested package NDC
85161-159-01
11-digit product format
851610159
Labeler code
85161
Product ID
85161-159_452b6f22-5081-86ab-e063-6394a90a0416
Type
HUMAN OTC DRUG
Nonproprietary name
Homosalate,Octocrylene,Octisalate,Avobenzone
Dosage form
LIQUID
Route
TOPICAL
Labeler
Longway Technology(Guangzhou)Co.,Ltd.
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-15
Substance
HOMOSALATE; OCTOCRYLENE; AVOBENZONE; OCTISALATE
Active strength
.05; .045; .03; .04 g/mL; g/mL; g/mL; g/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HOMOSALATE.05 g/mL
OCTOCRYLENE.045 g/mL
AVOBENZONE.03 g/mL
OCTISALATE.04 g/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
G63QQF2NOXInternal UNII lookup
4X49Y0596WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
452b6f22-5080-86ab-e063-6394a90a0416Available 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
85161-159-01Poolside Frostbite Sunscreen Papaya SPF 15 Scented lip gloss1 in 1 BOXLIQUID11
85161-159-01Poolside Frostbite Sunscreen Papaya SPF 15 Scented lip gloss15 mL in 1 BOTTLE, GLASSLIQUID151

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 213 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Age Defense for Eyes 5 in 1ZINC OXIDE AND TITANIUM DIOXIDETopiderm, Inc.48d5343a-1068-4c64-a275-c180026d69472025-06-03WarningsExact identifier
application number: M020
Ola Botanicals Sunscreen SPF 30ZINC OXIDENatural Health Partners, LLCc7a7df0b-da8f-407d-a1ee-28f75070b23c2025-06-02WarningsExact identifier
application number: M020
MUSTELA MINERAL SUNSCREEN BROAD SPECTRUM SPF 50ZINC OXIDEExpanscience Laboratories d/b/a Mustela95ea5442-a7ca-0c7d-e053-2a95a90ad2472025-06-02WarningsExact identifier
application number: M020
Bluevado SunfixZINC OXIDE, TITANIUM DIOXIDEMagic Blue, LLC31f1e961-3719-f70a-e063-6394a90a481e2025-05-31WarningsExact identifier
application number: M020
Sunny Sailor First Mate Face Stick SPF 30ZINC OXIDESUNNY SAILOR LLC8ef7e0c8-e76b-4e84-ac9d-169f85e5e36e2025-05-28WarningsExact identifier
application number: M020
Dr Mercola Broad Spectrum SPF15ZINC OXIDENatural Health Partners, LLC47f6b19e-ede8-0daf-e054-00144ff88e882025-05-28WarningsExact identifier
application number: M020
Dr. Mercola Broad SpectrumZINC OXIDENatural Health Partners, LLC47f6ec0a-1144-55dd-e054-00144ff8d46c2025-05-28WarningsExact identifier
application number: M020
Dr. Mercola Broad SpectrumTITANIUM DIOXIDE, ZINC OXIDENatural Health Partners, LLC47f6ab9e-fa73-496a-e054-00144ff8d46c2025-05-28WarningsExact identifier
application number: M020
Celavive Protective Day SPF 30AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTOCRYLENEUSANA Health Sciences, Inc.cf00763f-6b3e-4d50-b639-9a6d6f5959612025-05-28WarningsExact identifier
application number: M020
TALLOW SUNSCREENNON-NANO ZINC OXIDEFOUNDATION COMMERCE INC363e38bf-b4b4-dcc4-e063-6294a90a5d2f2025-05-28WarningsExact identifier
application number: M020
CoreTex SunX 50 FacestickAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENECoreTex Products Inc364989ea-c93b-d404-e063-6294a90abd092025-05-28WarningsExact identifier
application number: M020
Solvaderm Universal Tinted Moisturizer Sunscreen SPF 30OCTINOXATE, ZINC OXIDESOLVADERM LLC86dbd8c3-e95a-49a8-afe6-ff9d985e28ba2025-05-27WarningsExact identifier
application number: M020
NATUREWELL HYDRASUN LIP BALM SPF30 CITRUS SPRITZAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE LIP BALMPort Jervis Laboratories, Inc.350b4cce-1627-5b8f-e063-6294a90aa6bf2025-05-26WarningsExact identifier
application number: M020
Protect Daily Ritual Mineral Sunscreen TintedTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35ce8307-387b-2b40-e063-6294a90a28bc2025-05-23Exact identifier
application number: M020
OS-01 FACE SPF BD SPF 30 TINTED MEDIUM/DEEPZINC OXIDEONESKIN INC.35d57d3f-376c-2307-e063-6294a90adf512025-05-23WarningsExact identifier
application number: M020
Oathology Inzincable Lip Balm SPF 35ZINC OXIDESKINOATH LLC289a5492-af57-42e5-82af-3f1e4b369d682025-05-22WarningsExact identifier
application number: M020
NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, LightZINC OXIDEALLI LLC3cb4459b-1776-414a-b5c4-0ffb9f1df7662025-05-22WarningsExact identifier
application number: M020
NAELI Tinted Mineral Moisturizer Sunscreen SPF 50, DarkZINC OXIDEALLI LLC81633684-f9ac-45cb-8a3e-f0c30b229a822025-05-22WarningsExact identifier
application number: M020
Mineral Lip SunscreenTITANIUM DIOXIDE, ZINC OXIDEMelinda Menezes, M.D., Inc.35bea4f3-c19e-3e2e-e063-6394a90aeb692025-05-22Exact identifier
application number: M020
LBEL FOREVER HYDRA LONGWEAR AND HYDRATING FOUNDATION 90H SPF 15 ALMENDRA 230NOCTINOXATE, ZINC OXIDEBEL STAR S.A.35c106b6-9a80-01e3-e063-6294a90abc352025-05-22WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
85161-159-01851610159011 BOTTLE, GLASS in 1 BOX (85161-159-01) / 15 mL in 1 BOTTLE, GLASS2026-01-15NoNoCurrent