SUNSCREEN

Product NDC: 82953-025
11-digit product format: 829530025
Labeler code: 82953
Product ID: 82953-025_229d8002-259a-f252-e063-6394a90adda1
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone,Homosalate,Octocrylene,Octisalate
Dosage form: SPRAY
Route: TOPICAL
Labeler: Cosmuses Cosmetics (Ningbo) Co., Ltd.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-05-30
Substance: OCTOCRYLENE; HOMOSALATE; AVOBENZONE; OCTISALATE
Active strength: 10; 10; 3; 5 g/100mL; g/100mL; g/100mL; g/100mL
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: SUNSCREEN
Brand name suffix: 01
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTOCRYLENE	10 g/100mL
HOMOSALATE	10 g/100mL
AVOBENZONE	3 g/100mL
OCTISALATE	5 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
5A68WGF6WM	Internal UNII lookup
V06SV4M95S	Internal UNII lookup
G63QQF2NOX	Internal UNII lookup
4X49Y0596W	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
229dabbc-9043-3c9d-e063-6394a90a5692	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
82953-025-01	SUNSCREEN01	10 mL in 1 BOTTLE, PLASTIC	SPRAY	10	1
82953-025-02	SUNSCREEN01	20 mL in 1 BOTTLE, PLASTIC	SPRAY	20	1
82953-025-03	SUNSCREEN01	25 mL in 1 BOTTLE, PLASTIC	SPRAY	25	1
82953-025-04	SUNSCREEN01	15 mL in 1 BOTTLE, PLASTIC	SPRAY	15	1
82953-025-05	SUNSCREEN01	8 mL in 1 BOTTLE, PLASTIC	SPRAY	8	1
82953-025-06	SUNSCREEN01	18 mL in 1 BOTTLE, PLASTIC	SPRAY	18	1
82953-025-07	SUNSCREEN01	5 mL in 1 BOTTLE, PLASTIC	SPRAY	5	1
82953-025-08	SUNSCREEN01	30 mL in 1 BOTTLE, PLASTIC	SPRAY	30	1
82953-025-09	SUNSCREEN01	60 mL in 1 BOTTLE, PLASTIC	SPRAY	60	1
82953-025-10	SUNSCREEN01	90 mL in 1 BOTTLE, PLASTIC	SPRAY	90	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82953-025	SUNSCREEN 01 (AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE) SPRAY [COSMUSES COSMETICS (NINGBO) CO., LTD.]	1	Current NDC, 10 package rows	20240922_229dabbc-9043-3c9d-e063-6394a90a5692.zip

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 269 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Banana Boat	ZINC OXIDE	Edgewell Personal Care Brands LLC	1ce728be-966e-b662-e063-6394a90a0ba8	2024-10-30	Warnings	Exact identifier application number: M020
RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	COSMAX USA, INC.	2596a17e-4042-3544-e063-6294a90aa4c9	2024-10-29	Warnings	Exact identifier application number: M020
Sunblocz	ZINC OXIDE	Olen Skin Care Corporation	36fec1f1-5e8b-5764-e054-00144ff8d46c	2024-10-29	Warnings	Exact identifier application number: M020
Sunblocz Baby and Kids	ZINC OXIDE	Olen Skin Care Corporation	35cbb9d5-639c-207a-e054-00144ff88e88	2024-10-29	Warnings	Exact identifier application number: M020
ZO Skin Health Daily Sheer Broad-Spectrum Sunscreen SPF 50 Water Resistant (40 Minutes)	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	ZO Skin Health, Inc.	fd7d40fe-178a-e1b1-e053-6294a90a29a1	2024-10-29	Warnings	Exact identifier application number: M020
ZO Skin Health Sunscreen Plus Primer Broad-Spectrum SPF 30	TITANIUM DIOXIDE AND ZINC OXIDE	ZO Skin Health, Inc.	9a4f5be1-da04-48b9-897a-57f4a3d9d1ec	2024-10-29	Warnings	Exact identifier application number: M020
TiZO Ultra Zinc SPF 40 (Non-Tinted)	ZINC OXIDE	Fallien Cosmeceuticals, LTD	e4a06973-21bb-4eda-9b74-fc23bee141ab	2024-10-29	Warnings	Exact identifier application number: M020
TiZO Ultra Zinc SPF 40 (Tinted)	ZINC OXIDE	Fallien Cosmeceuticals, LTD	36efd48b-910e-4b61-9519-a6d5c7e9a7c3	2024-10-29	Warnings	Exact identifier application number: M020
ZO Skin Health Broad-Spectrum Sunscreen SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	ZO Skin Health, Inc.	d817f80b-a998-b67e-e053-2995a90a1971	2024-10-29	Warnings	Exact identifier application number: M020
SPF 15 Coconut Lip Balm	ZINC OXIDE	Naples Soap Company, Inc.	25a7510f-5ef3-9920-e063-6394a90a2079	2024-10-29	Warnings	Exact identifier application number: M020
Defense Total High Protection SPF 50 No Color Daily Non-Greasy Face Protection	HOMOSALATE, OCTOCRYLENE, AVOBENZONE	Bel Star S.A. (Colombia)	a7d69691-cecc-798e-e053-2a95a90a995f	2024-10-28	Warnings	Exact identifier application number: M020
LBEL FOREVER ULTRA MATTE BASE CONTROL BRILLO DE LARGA DURACION FPS 15 SHINE CONTROL LONGWEAR FOUNDATION SPF 15 LATTE 180-F	OCTINOXATE, ZINC OXIDE	Bel Star S.A.	eea17271-e8c8-ab21-e053-2995a90a2fcc	2024-10-28	Warnings	Exact identifier application number: M020
LBEL SPECIALISTE DARK SPOT BRIGHTENING MOISTURIZING SPF 30	AVOBENZONE, OCTISALATE, OCTOCRYLENE	BEL STAR SA	fd90ffc6-a1e1-e02e-e053-6294a90a4e7c	2024-10-28	Warnings	Exact identifier application number: M020
LBEL SOLUTIONS PRO-HIALURON BASE SERUM CON EFECTO RELLENO DE ARRUGAS FPS 15 WRINKLE FILLER EFFECT SERUM FOUNDATION SPF 15 CHAMPAGNE 170-N	OCTINOXATE, ZINC OXIDE	BEL STAR S.A.	0b782198-58e7-5343-e063-6294a90a3713	2024-10-28	Warnings	Exact identifier application number: M020
FHF Elevated Shade 100% Mineral Sunscreen	SUNSCREEN	Owen Biosciences Inc	dabd3b95-01d3-014c-e053-2a95a90a0fec	2024-10-28	Warnings	Exact identifier application number: M020
RECIPE Infinite UV Shield Sunscreen Broad Spectrum SPF100	AVOBENZONE, HOMOSALATE, OCTINOXATE, OCTISALATE, OCTOCRYLENE	BAY BELLE LABS	259653e7-dfe0-44a2-e063-6294a90a416d	2024-10-28	Warnings	Exact identifier application number: M020
Banana Boat	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	8a21acbe-2f3d-cf78-e053-2a95a90a77f6	2024-10-27	Warnings	Exact identifier application number: M020
Banana Boat	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	7961ff9f-75db-4977-e053-2a91aa0ae628	2024-10-27	Warnings	Exact identifier application number: M020
Banana Boat Light as air face SUNSCREEN UVA UVB Broad Spectrum SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	8a1c9a3c-394e-9122-e053-2995a90acb23	2024-10-27	Warnings	Exact identifier application number: M020
Banana Boat	AVOBENZONE, HOMOSALATE, OCTOCRYLENE	Edgewell Personal Care Brands LLC	8b889b75-07ac-4276-e053-2a95a90a69c6	2024-10-27	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
82953-025-01	82953002501	10 mL in 1 BOTTLE, PLASTIC (82953-025-01)	10 ml	2024-05-30	No	No	Current
82953-025-02	82953002502	20 mL in 1 BOTTLE, PLASTIC (82953-025-02)	20 ml	2024-05-30	No	No	Current
82953-025-03	82953002503	25 mL in 1 BOTTLE, PLASTIC (82953-025-03)	25 ml	2024-05-30	No	No	Current
82953-025-04	82953002504	15 mL in 1 BOTTLE, PLASTIC (82953-025-04)	15 ml	2024-05-30	No	No	Current
82953-025-05	82953002505	8 mL in 1 BOTTLE, PLASTIC (82953-025-05)	8 ml	2024-05-30	No	No	Current
82953-025-06	82953002506	18 mL in 1 BOTTLE, PLASTIC (82953-025-06)	18 ml	2024-05-30	No	No	Current
82953-025-07	82953002507	5 mL in 1 BOTTLE, PLASTIC (82953-025-07)	5 ml	2024-05-30	No	No	Current
82953-025-08	82953002508	30 mL in 1 BOTTLE, PLASTIC (82953-025-08)	30 ml	2024-05-30	No	No	Current
82953-025-09	82953002509	60 mL in 1 BOTTLE, PLASTIC (82953-025-09)	60 ml	2024-05-30	No	No	Current
82953-025-10	82953002510	90 mL in 1 BOTTLE, PLASTIC (82953-025-10)	90 ml	2024-05-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
sunscreen spray SPF30 (update 240921)	Cosmuses Cosmetics (Ningbo) Co., Ltd.	2024-09-21	HUMAN OTC DRUG LABEL	1