FDA.reportPublic FDA data

PoutScreen Lip Treatment Candy Cane

Product NDC
81104-598
11-digit product format
811040598
Labeler code
81104
Product ID
81104-598_47d2360a-0b96-1e45-e063-6294a90a97ae
Type
HUMAN OTC DRUG
Nonproprietary name
Avobenzone, Octinoxate, Octocrylene
Dosage form
LIQUID
Route
TOPICAL
Labeler
NAKED SUNDAYS PTY LTD
Application
M020
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-12-18
Substance
OCTINOXATE; AVOBENZONE; OCTOCRYLENE
Active strength
7.5; 2.5; 10 g/100mL; g/100mL; g/100mL
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
PoutScreen Lip Treatment Candy Cane
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
OCTINOXATE7.5 g/100mL
AVOBENZONE2.5 g/100mL
OCTOCRYLENE10 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5A68WGF6WMInternal UNII lookup
4Y5P7MUD51Internal 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
47d22c6d-49fd-f97c-e063-6294a90a6ba1Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81104-598-01PoutScreen Lip Treatment Candy Cane15 mL in 1 TUBE, WITH APPLICATORLIQUID151
81104-598-02PoutScreen Lip Treatment Candy Cane1 in 1 CARTONLIQUID11

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 100 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Medium TanHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC47387d5f-e77b-5633-e063-6294a90a55842025-12-30WarningsExact identifier
application number: M020
Ageless Glow Serum BB Cream Sunscreen SPF 40 - TanHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4738be66-0fe8-148e-e063-6394a90a1b022025-12-30WarningsExact identifier
application number: M020
Ageless Glow Serum BB Cream Sunscreen SPF 40 - Tan DeepHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4738eed1-9f72-5fd8-e063-6394a90a26bd2025-12-30WarningsExact identifier
application number: M020
Ageless Glow Serum BB Cream Sunscreen SPF 40 - DeepHOMOSALATE, TITANIUM DIOXIDE, ZINC OXIDEPur-lisse Beauty, LLC4739179e-88b3-8820-e063-6394a90aa2112025-12-30WarningsExact identifier
application number: M020
WHITE TEA TINTED MOISTURIZERWHITE TEA TINTED MOISTURIZER BROAD SPECTRUM SPF 30 SUNSCREENGLOW CONCEPT INCeb2df93f-6cdc-7ae8-e053-2a95a90a00912025-12-29WarningsExact identifier
application number: M020
Hawaiian Natural Zinc Sunscreen SPF 50ZINC OXIDEKokua Sun Care64a5589b-735d-38ba-e053-2a91aa0ad8f42025-12-29WarningsExact identifier
application number: M020
Hawaiian Natural Zinc Sunscreen Broad Spectrum Tinted SPF 30ZINC OXIDEKokua Sun Caref9a12dac-2fd0-798f-e053-6394a90aa7842025-12-29WarningsExact identifier
application number: M020
Calming Days Vegan Sunscreen,OCTYL TRIAZONE (ETHYLHEXYL TRIAZONE), BISOCTRIZOLE, DIETHYLHEXYL BUTAMIDO TRIAZONE, DIETHYLAMINO HYDROXYBENZOYL HEXYL BENZOATEMERCYCO Co., Ltd.38898014-eefe-73ec-e063-6394a90a37382025-12-29WarningsExact identifier
application number: M020
SPF 30 SunscreenZINC OXIDE, TITANIUM DIOXIDECLEUREf5512f34-08ee-b0f6-e053-2a95a90ab5bd2025-12-29WarningsExact identifier
application number: M020
COCO AND EVE SUNNY HONEY PROTECT TAN BOOSTING ANTI-AGING SPF 20SUNSCREEN OILSoleil Collective LLC471b3028-2c13-ab70-e063-6394a90aa6602025-12-29WarningsExact identifier
application number: M020
COCO AND EVE SUNNY HONEY PROTECT TAN BOOSTING ANTI-AGING SPF 45SUNSCREEN OILSoleil Collective LLC471c0eed-f7ca-3c3b-e063-6294a90ad2c62025-12-29WarningsExact identifier
application number: M020
EIGHT HOUR NOURISHING LIP SPF 20OCTINOXATE, AVOBENZONEREVLONb3c16e60-752d-6eba-e053-2995a90a2b202025-12-29WarningsExact identifier
application number: M020
CERAMIDE PREMIERE BROAD SPECTRUM SPF 30OCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONEREVLONb3358bfd-7fe5-33e2-e053-2a95a90ac2ea2025-12-29WarningsExact identifier
application number: M020
Prevage anti aging SPF 30OCTISALATE, OCTINOXATE, OXYBENZONE, AVOBENZONE, OCTOCRYLENE,Revlonb2bff796-1579-2686-e053-2995a90ad6c72025-12-29WarningsExact identifier
application number: M020
FLAWLESS FUTURE SPF 30OCTINOXATE, OCTISALATE, OXYBENZONE, AVAOBENZONEREVLONb553aec1-5002-3a3f-e053-2995a90a22e52025-12-29WarningsExact identifier
application number: M020
Prevage Anti-aging eye cream SPF 15OCTINOXATE, OXYBENZONERevlonb2a92d72-e634-7379-e053-2995a90a2bca2025-12-29WarningsExact identifier
application number: M020
Prevage Anti-aging Moisture CreamOCTINOXATE, OCTISALATE, OXYBENZONE, OCTOCRYLENE, AVOBENZONERevlon Consumer Products Corpb247adbe-dfe8-df0a-e053-2995a90a34d92025-12-29WarningsExact identifier
application number: M020
Sheer Protection SPF 30ZINC OXIDESkin Script, LLC0450dcc9-3f8f-e2c2-e063-6294a90af60b2025-12-29WarningsExact identifier
application number: M020
RE-NUTRIV ULTRA RADIANCE MAKEUP BROAD SPECTRUM SPF 20OCTINOXATE AND TITANIUM DIOXIDEESTEE LAUDER INC897b8edb-f089-4a49-baca-e05806b0a0682025-12-29WarningsExact identifier
application number: M020
Mine Line Coconut Sunscreen SPF 50ZINC OXIDESpa de Soleil4642b1cc-43b1-6997-e063-6394a90ac7642025-12-29WarningsExact identifier
application number: M020

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
81104-598-018110405980115 mL in 1 TUBE, WITH APPLICATOR15 mlHistorical
81104-598-02811040598021 TUBE, WITH APPLICATOR in 1 CARTON (81104-598-02) / 15 mL in 1 TUBE, WITH APPLICATOR (81104-598-01) 2025-12-18NoNoCurrent