PoutScreen Lip Treatment Midnight Kiss

Product NDC: 81104-596
11-digit product format: 811040596
Labeler code: 81104
Product ID: 81104-596_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 Midnight Kiss
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	7.5 g/100mL
AVOBENZONE	2.5 g/100mL
OCTOCRYLENE	10 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4Y5P7MUD51	Internal UNII lookup
G63QQF2NOX	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
47d22c6d-49fd-f97c-e063-6294a90a6ba1	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
81104-596-01	PoutScreen Lip Treatment Midnight Kiss	15 mL in 1 TUBE, WITH APPLICATOR	LIQUID	15		1
81104-596-02	PoutScreen Lip Treatment Midnight Kiss	1 in 1 CARTON	LIQUID	1		1

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 318 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE	The Honest Company, Inc.	c172d584-7cb6-a078-e053-2995a90ac78f	2023-12-05	Warnings	Exact identifier application number: M020
EltaMD UV Sheer	ZINC OXIDE AND OCTOCRYLENE SUNSCREEN	CP Skin Health Group, Inc.	2564e811-70f5-4d00-be8e-686b55e31630	2023-12-05	Warnings	Exact identifier application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c1720cff-a897-68cb-e053-2995a90a30b6	2023-12-05	Warnings	Exact identifier application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c12272c3-d4ed-2212-e053-2995a90add37	2023-12-05	Warnings	Exact identifier application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c12272c3-d4f0-2212-e053-2995a90add37	2023-12-05	Warnings	Exact identifier application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c1228ca6-8fb4-5964-e053-2a95a90a30ca	2023-12-05	Warnings	Exact identifier application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c12292a8-c98f-eb27-e053-2a95a90a9bbc	2023-12-05	Warnings	Exact identifier application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE	The Honest Company, Inc.	c172d22a-0315-8e84-e053-2995a90a30b5	2023-12-05	Warnings	Exact identifier application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE	The Honest Company, Inc.	c172cabe-faab-6458-e053-2995a90aef66	2023-12-05	Warnings	Exact identifier application number: M020
Sea Clearly Translucent Gel Sunscreen BS SPF 50	HOMOSALATE, OCTOCRYLENE, OCTISALATE, AVOBENZONE	Allure Labs	0bb4ec66-64ba-9583-e063-6394a90ac512	2023-12-04	Warnings	Exact identifier application number: M020
Clearly Zinq Mineral Gel Sunscreen BS SPF 60	ZINC OXIDE	Allure Labs	0bb7f0a4-13df-7734-e063-6294a90a242b	2023-12-04	Warnings	Exact identifier application number: M020
RECHARGE Regimen for Balancing, Boosting and Defending Healthy-Looking skin	TITANIUM DIOXIDE, ZINC OXIDE	Rodan & Fields	b7401ff8-ca47-4c74-813c-99c5f28c0b6d	2023-12-04	Warnings	Exact identifier application number: M020
Eminence Bright Skin Moisturizer SPF 40 Sunscreen	ZINC OXIDE	Eminence Organic Skin Care	4f2ba93d-ec19-40c1-b4ca-53898841f55b	2023-12-02	Warnings	Exact identifier application number: M020
Lilikoi Mineral Defense Sport Sunscreen SPF 30	ZINC OXIDE	Eminence Organic Skin Care Ltd.	5375522a-17e3-48a1-8248-dd811c3823bf	2023-12-02	Warnings	Exact identifier application number: M020
Eminence Lilikoi Daily Defense Moisturizer SPF 40 Sunscreen	ZINC OXIDE	Eminence Organic Skin Care	edc9972a-affd-4099-aec1-3549a07fa83c	2023-12-02	Warnings	Exact identifier application number: M020
Perbelle CC SPF43 UVA UVB Broad Spectrum	TITANIUM DIOXIDE	Perbelle Cosmetics Global Ltd.	b5e2724e-9806-5bcc-e053-2a95a90a0508	2023-12-01	Warnings	Exact identifier application number: M020
A PERFECT WORLD SPF 40 AGE DEFENSE BROAD SPECTRUM MOISTURIZER WITH WHITE TEA	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, AND OCTOCRYLENE	ORIGINS NATURAL RESOURCES INC.	abd8b302-a01c-478d-919a-22e686cb88da	2023-12-01	Warnings	Exact identifier application number: M020
SHADE and ILLUMINATE SOFT RAD PRMR SPF	OCTINOXATE,OCTISALATE,ZINC OXIDE	TOM FORD BEAUTY DIST	eac7d416-c243-4647-e053-2a95a90abcb7	2023-12-01	Warnings	Exact identifier application number: M020
CCC Clean Corrective with Vitamin C Tinted Moisturizer Broad Spectrum SPF 30	ZINC OXIDE, TITANIUM DIOXIDE	The Honest Company, Inc.	c1228d15-a157-6989-e053-2995a90a44ea	2023-12-01	Warnings	Exact identifier application number: M020
CAO Cosmetic Lip Sunscreen SPF 30	AVOBENZONE, OCTOCRYLENE	S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED	d912b9e9-f351-e2b0-e053-2a95a90a9ca2	2023-11-30	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
81104-596-01	81104059601	15 mL in 1 TUBE, WITH APPLICATOR	15 ml				Historical
81104-596-02	81104059602	1 TUBE, WITH APPLICATOR in 1 CARTON (81104-596-02) / 15 mL in 1 TUBE, WITH APPLICATOR (81104-596-01)		2025-12-18	No	No	Current