SUNSCREEN

Product NDC: 82953-002
11-digit product format: 829530002
Labeler code: 82953
Product ID: 82953-002_286c5fbb-74be-7de3-e063-6394a90a0973
Type: HUMAN OTC DRUG
Nonproprietary name: Avobenzone,Homosalate,Octocrylene,Octisalate
Dosage form: CREAM
Route: TOPICAL
Labeler: Cosmuses Cosmetics (Ningbo) Co., Ltd.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-09-26
Substance: OCTOCRYLENE; HOMOSALATE; AVOBENZONE; OCTISALATE
Active strength: 10; 10; 3; 5 g/100g; g/100g; g/100g; g/100g
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/100g
HOMOSALATE	10 g/100g
AVOBENZONE	3 g/100g
OCTISALATE	5 g/100g

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
e98c3b64-edcb-16c7-e053-2a95a90a8a0e	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
82953-002-01	SUNSCREEN01	10 g in 1 BOTTLE, PLASTIC	CREAM	10	4
82953-002-02	SUNSCREEN01	20 g in 1 BOTTLE, PLASTIC	CREAM	20	4
82953-002-03	SUNSCREEN01	30 g in 1 BOTTLE, PLASTIC	CREAM	30	4
82953-002-04	SUNSCREEN01	35 g in 1 BOTTLE, PLASTIC	CREAM	35	4
82953-002-05	SUNSCREEN01	45 g in 1 BOTTLE, PLASTIC	CREAM	45	4
82953-002-06	SUNSCREEN01	50 g in 1 BOTTLE, PLASTIC	CREAM	50	4
82953-002-07	SUNSCREEN01	57 g in 1 BOTTLE, PLASTIC	CREAM	57	4
82953-002-08	SUNSCREEN01	1.5 g in 1 BOTTLE, PLASTIC	CREAM	1.5	4

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82953-002	SUNSCREEN 01 (AVOBENZONE,HOMOSALATE,OCTOCRYLENE,OCTISALATE) CREAM [COSMUSES COSMETICS (NINGBO) CO., LTD.]	4	Current NDC, Legacy NDC, 8 package rows	20241206_e98c3b64-edcb-16c7-e053-2a95a90a8a0e.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 270 of 346 · 6,912 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Banana Boat Ultra Sport Sunscreen Broad Spectrum SPF 15	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands, LLC	9751a700-5d51-357b-e053-2a95a90af66c	2024-10-27	Warnings	Exact identifier application number: M020
Banana Boat Sport Ultra Face SPF30	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	dc757b03-7e7d-b362-e053-2a95a90a8446	2024-10-27	Warnings	Exact identifier application number: M020
Banana Boat Kids Mineral Protection SPF50	TITANIUM DIOXIDE,ZINC OXIDE	Edgewell Personal Care Brands LLC	dc7701b5-0c73-b4df-e053-2a95a90a0f1b	2024-10-27	Warnings	Exact identifier application number: M020
Banana Boat Mineral Sensitive SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Edgewell Personal Care Brands LLC	dc7913d5-58f2-3077-e053-2a95a90a1627	2024-10-27	Warnings	Exact identifier application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 30	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	e5f9d56d-a80e-221c-e053-2a95a90aae92	2024-10-27	Warnings	Exact identifier application number: M020
Banana Boat Mineral Sensitive Face SPF50	TITANIUM DIOXIDE, ZINC OXIDE	Edgewell Personal Care Brands LLC	dc783438-b28f-b7f4-e053-2a95a90a3d65	2024-10-27	Warnings	Exact identifier application number: M020
BANANA BOAT PROTECTION PLUS VITAMINS SUNSCREEN UVA/UVB BORAD SPECTRUM SPF 30	AVOBENZONE,HOMOSALATE,OCTISALATE,OCTOCRYLENE	Edgewell Personal Care Brands LLC	e53509bf-6bb7-2db7-e053-2a95a90aae18	2024-10-27	Warnings	Exact identifier application number: M020
Banana Boat Sport Mineral SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Edgewell Personal Care Brands LLC	dc79790f-e2bc-5414-e053-2a95a90a9e7a	2024-10-27	Warnings	Exact identifier application number: M020
TiZO Mineral Stick - Tinted SPF 45	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	fd6d0080-0bef-4e7e-8ca5-b859639efd0c	2024-10-25	Warnings	Exact identifier application number: M020
Alumier MD Post Procedure Kit with Hydrocortisone	TITANIUM DIOXIDE, ZINC OXIDE, HYDROCORTISONE	Alumier Labs	2551d748-c3d6-cd18-e063-6294a90adab6	2024-10-25	Warnings	Exact identifier application number: M020
TiZO Mineral Stick Non-Tinted SPF 45	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	e7044f18-992a-4f60-9a2b-f11ed06db09b	2024-10-25	Warnings	Exact identifier application number: M020
CoTZ Lip Balm	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals, LTD	479a7d82-a068-4c2e-b50b-555c40e13e37	2024-10-25	Warnings	Exact identifier application number: M020
TiZO Mineral Sun Defense SPF 50	TITANIUM DIOXIDE, ZINC OXIDE	Fallien Cosmeceuticals Ltd.	e17a8c35-2d49-4c99-b154-ea673c14753e	2024-10-25	Warnings	Exact identifier application number: M020
IPKN Moist and Firm Beauty Balm Light Medium	TITANIUM DIOXIDE	Inel Cosmetics Co., Ltd.	1af6184e-3dc4-4eb3-8d51-aca724473451	2024-10-25	Warnings	Exact identifier application number: M020
IPKN Moist and Firm Beauty Balm Light	TITANIUM DIOXIDE	Inel Cosmetics Co., Ltd.	77d77838-aa13-4939-a1a0-50189fbb3fe0	2024-10-25	Warnings	Exact identifier application number: M020
Dove Men plus Care Hydrate Face	AVOBENZONE, ENSULIZOLE, OCTISALATE, OCTOCRYLENE	CONOPCO Inc. d/b/a Unilever	afe75aff-c056-eaf7-e053-2a95a90af71b	2024-10-24	Warnings	Exact identifier application number: M020
Cancer Council Mineral Fluid SPF50	ZINC OXIDE	Vitality US Co.	1638f8a4-a2da-4e1f-e063-6294a90a03d9	2024-10-24	Warnings	Exact identifier application number: M020
Marlowe SPF 50	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Marlowe Holdings, LLC	f94bd91a-f0ab-680c-e053-6394a90ac855	2024-10-23	Warnings	Exact identifier application number: M020
Vacation Broad Spectrum SPF 30	HOMOSALATE, OCTISALATE, OCTOCRYLENE, AVOBENZONE	Vacation Inc.	2526eadf-4b55-ff81-e063-6394a90a3ba7	2024-10-23	Warnings	Exact identifier application number: M020
Tenacious Ergodyne	KREWD CLEAR SPF 50 CONTINUOUS SPRAY	Tenacious Holdings, Inc.	55d99d0a-dc7f-4915-b7c1-f999c8b36e0d	2024-10-23	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	Marketing end	Sample	Exclude flag	Status
82953-002-01	82953000201	10 g in 1 BOTTLE, PLASTIC (82953-002-01)	10 g	2022-09-26	0000-00-00	No	No	Current
82953-002-02	82953000202	20 g in 1 BOTTLE, PLASTIC (82953-002-02)	20 g	2022-09-26	0000-00-00	No	No	Current
82953-002-03	82953000203	30 g in 1 BOTTLE, PLASTIC (82953-002-03)	30 g	2022-09-26	0000-00-00	No	No	Current
82953-002-04	82953000204	35 g in 1 BOTTLE, PLASTIC (82953-002-04)	35 g	2022-09-26	0000-00-00	No	No	Current
82953-002-05	82953000205	45 g in 1 BOTTLE, PLASTIC (82953-002-05)	45 g	2022-09-26	0000-00-00	No	No	Current
82953-002-06	82953000206	50 g in 1 BOTTLE, PLASTIC (82953-002-06)	50 g	2022-09-26	0000-00-00	No	No	Current
82953-002-07	82953000207	57 g in 1 BOTTLE, PLASTIC (82953-002-07)	57 g	2022-09-26		No	No	Current
82953-002-08	82953000208	1.5 g in 1 BOTTLE, PLASTIC (82953-002-08)	1.5 g	2022-09-26		No	No	Current