What is NDC 81104-597?

81104-597 is the product NDC for PoutScreen Lip Treatment Darling, Octinoxate 7.5 g/100mL + 2 more ingredients liquid, listed with the FDA by NAKED SUNDAYS PTY LTD. It has 1 package NDC, shown above in 10- and 11-digit form.

What drug is associated with this NDC?

PoutScreen Lip Treatment Darling (Avobenzone, Octinoxate, Octocrylene).

What is the active ingredient?

Octinoxate, Avobenzone, Octocrylene.

NAKED SUNDAYS PTY LTD, NDC labeler code 81104. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.

What other NDCs exist for PoutScreen Lip Treatment Darling?

None: this is the only finished product listed under this name.

Is there a related HCPCS / J-code?

Not in Med-Code's curated HCPCS directory.

PoutScreen Lip Treatment Darling NDC 81104-597

NDC codes

FDA NDC Directory

Product NDC (as listed)81104-597Labeler and product segments. Claims need a package NDC.

Product NDC at billing width81104-0597Add the package segment from the table below.

Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC	11-digit (billing)	Package	Copy
81104-597-02	8110405970281104059702	1 TUBE, WITH APPLICATOR in 1 CARTON (81104-597-02) / 15 mL in 1 TUBE, WITH APPLICATOR (81104-597-01)Marketed from Dec 18, 2025

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary): PoutScreen Lip Treatment Darling
Generic name (nonproprietary): avobenzone, octinoxate, octocrylene
Active ingredients: Octinoxate — 7.5 g/100mLAvobenzone — 2.5 g/100mLOctocrylene — 10 g/100mL
Dosage form: Liquid
Route: Topical
Labeler: NAKED SUNDAYS PTY LTDNDC labeler code 81104
Product type: Over-the-counter drug
Marketing category: OTC monograph drugApplication M 020
Marketing start: Dec 18, 2025
Listing expires: Dec 31, 2027
Identifiers: Product ID 81104-597_47d2360a-0b96-1e45-e063-6294a90a97aeSPL ID 47d2360a-0b96-1e45-e063-6294a90a97aeSPL set ID 47d22c6d-49fd-f97c-e063-6294a90a6ba1UNII G63QQF2NOX, 4Y5P7MUD51, 5A68WGF6WM

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Topical products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N481104059702 followed by a unit qualifier and the quantity

Package 81104-0597-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective Jan 6, 2026.

Indications (excerpt from the label)

Use: • Helps prevent sunburn. • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin ageing caused by the sun

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

About NDC 81104-597

What is NDC 81104-597?: 81104-597 is the product NDC for PoutScreen Lip Treatment Darling, Octinoxate 7.5 g/100mL + 2 more ingredients liquid, listed with the FDA by NAKED SUNDAYS PTY LTD. It has 1 package NDC, shown above in 10- and 11-digit form.
What drug is associated with this NDC?: PoutScreen Lip Treatment Darling (Avobenzone, Octinoxate, Octocrylene).
What is the active ingredient?: Octinoxate, Avobenzone, Octocrylene.
Who is the labeler?: NAKED SUNDAYS PTY LTD, NDC labeler code 81104. The labeler is the company responsible for the label; it may be the manufacturer, a repackager or a distributor.
What other NDCs exist for PoutScreen Lip Treatment Darling?: None: this is the only finished product listed under this name.
Is there a related HCPCS / J-code?: Not in Med-Code's curated HCPCS directory. See Billing references above.

Other NDCs under M 020

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 020
Product	Strength	Form · route	Labeler	Product NDC
bareMinerals Original Foundation Broad Spectrum SPF 15 Light 08titanium dioxide and zinc oxide	Titanium dioxide 1440 mg/8g; Zinc oxide 1760 mg/8g	PowderTopical	Orveon Global US LLC	98132-010
BelleJoss BROAD SPECTRUM SPF 50broad spectrum spf 50	Ethylhexyl methoxycinnamate 7.4925 mg/100mg	CreamTopical	Guangzhou Liyan Cosmetics Technology Co., Ltd.	87770-002
Mineral Based Foam Sunscreen Non-Tintedtitanium dioxide, zinc oxide	Titanium dioxide 30 mg/g; Zinc oxide 100 mg/g	Aerosol, FoamTopical	KATHLEEN P. HUTTON, M.D., INC. A PROFESSIONAL CORPORATION	81679-211
COOLA Classic Body SPF 50 Guava Mangoavobenzone, homosalate, octisalate, octocrylene	Avobenzone 2.9 g/100mL + 3 more ingredients	SprayTopical	COOLA, LLC	79753-059
Golden Rose Glow Kiss Tinted Lip Balm Vanilla Latteavobenzone, octinoxate	Avobenzone 2.7 g/100g; Octinoxate 6 g/100g	LipstickTopical	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	82715-109
Restore Plus Defense Acne Safe Facial Mineral Sunscreen Lightly Tintedzinc oxide	Zinc oxide 160 mg/g	CreamTopical	NY BEAUTY PALACE LLC	85404-208
Tinted Mineral Sunscreentitanium dioxide, zinc oxide	Titanium dioxide 80 mg/g; Zinc oxide 38 mg/g	CreamTopical	The Essential Brazilian Spa LLC	85492-203
Tinted Sunscreentitanium dioxide, zinc oxide	Titanium dioxide 80 mg/g; Zinc oxide 38 mg/g	CreamTopical	Scottsdale Skin Boutique and Dermatology Pllc	85331-203
First Aid Beauty FAB Ultra Light Mineral Sunscreen Broad Spectrum SPF 30zinc oxide	Zinc oxide 22 g/100mL	LiquidTopical	The Procter & Gamble Manufacturing Company	84126-214
the beach people SPF 15zinc oxide	Zinc oxide 12 g/100mL	LotionTopical	The Beach People United LLC	84530-100
Tinted Sunscreen Broad SPF30	Zinc oxide 7.5 g/100g; Titanium dioxide 3.2 g/100g	CreamTopical	DOSCHER FAMILY HEALTH NP P.C.	84608-0651
Flawless Future SPF 30octinoxate, octisalate, oxybenzone, avaobenzone	Octinoxate 7.14 mg/g + 3 more ingredients	EmulsionTopical	REVLON	10967-683
Lbel Forever Matte Base Control Brillo Y Larga Duracion 48H Fps 15 Control And Longwear Foundation 48H SPF 15 Latte 180-Foctinoxate, zinc oxide	Octinoxate 50 mg/g; Zinc oxide 49 mg/g	EmulsionTopical	BEL STAR S.A.	14141-342
Pro-Tect Sports Sunscreenmeradimate, octinoxate, octisalate, oxybenzone	Octinoxate 75 mg/g + 3 more ingredients	LotionCutaneous	Bio-Medical & Pharmaceutical Manufacturing Corporation	37945-862
ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30titanium dioxide and zinc oxide	Titanium dioxide 10 mg/mL; Zinc oxide 200 mg/mL	CreamTopical	ZO Skin Health, Inc.	42851-060
Artistry Exact Fit Longwearing Foundation Shade Golden L4N1titanium dioxide	Titanium dioxide 40.25 mg/mL	CreamTopical	Amway Corp	50390-205
Derma B Everyday Fit Sunscreen SPF 50avobezone, homosalate, octisalate, octocrylene	Avobenzone 30 mg/mL + 3 more ingredients	LotionTopical	NeoPharm Co., Ltd.	51141-0701
Cell Fusion C Laser UV Defense Sunscreen Broad Spectrum SPF 50homosalate, octisalate, octocrylene, zinc oxide	Homosalate 6 g/50mL + 3 more ingredients	CreamTopical	CMS LAB Inc.	52554-9062
SPF 30 Sunscreenavobenzone, homosalate, octisalate, octocrylene	Avobenzone 30 mg/g + 3 more ingredients	Aerosol, SprayTopical	DEMOULAS SUPER MARKETS, INC	53942-002
Amazonian Clay BB Tinted Moisturizer Broad Spectrum SPF 20 Sunscreen Ivorytitanium dioxide and zinc oxide	Titanium dioxide 50 mg/mL; Zinc oxide 50 mg/mL	CreamTopical	PML NYC, LLC	59735-900

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PoutScreen Lip Treatment Darling (Avobenzone, octinoxate, octocrylene) NDC 81104-597