Sunscreen Emulsion SPF50plus

Product NDC: 84509-002
11-digit product format: 845090002
Labeler code: 84509
Product ID: 84509-002_2b3ecbec-979d-d07c-e063-6294a90a717a
Type: HUMAN OTC DRUG
Nonproprietary name: Octocrylene,Ethylhexyl Methoxycirnnamate,Titanium Dioxide,Ethylhexyl Salicylate
Dosage form: LOTION
Route: TOPICAL
Labeler: Guangzhou Senmai Biotechnology Co.
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2024-07-16
Substance: OCTISALATE; OCTOCRYLENE; OCTINOXATE; TITANIUM DIOXIDE
Active strength: 1500; 3000; 3000; 2400 mg/30mL; mg/30mL; mg/30mL; mg/30mL
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 Emulsion SPF50plus
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTISALATE	1500 mg/30mL
OCTOCRYLENE	3000 mg/30mL
OCTINOXATE	3000 mg/30mL
TITANIUM DIOXIDE	2400 mg/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4X49Y0596W	Internal UNII lookup
5A68WGF6WM	Internal UNII lookup
4Y5P7MUD51	Internal UNII lookup
15FIX9V2JP	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
1d560670-026b-bd34-e063-6394a90a9af4	Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
84509-002-01	Sunscreen Emulsion SPF50plus	30 mL in 1 BOTTLE	LOTION	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
84509-002	SUNSCREEN EMULSION SPF50PLUS (OCTOCRYLENE,ETHYLHEXYL METHOXYCIRNNAMATE,TITANIUM DIOXIDE,ETHYLHEXYL SALICYLATE) LOTION [GUANGZHOU SENMAI BIOTECHNOLOGY CO.]	3	Current NDC, 1 package rows	20250110_1d560670-026b-bd34-e063-6394a90a9af4.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 97 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Sei Bella CC Brightening Creme Light	OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%	Melaleuca Inc.	6894b9d9-a5b5-4c98-e053-2991aa0a9ca2	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella CC Brightening Creme Fair	OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%	Melaleuca Inc.	6892952a-d032-30bf-e053-2a91aa0a3bba	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella CC Brightening Creme Medium Tan	OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%	Melaleuca Inc.	68a4e8b4-36cb-6306-e053-2a91aa0a6d25	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella CC Brightening Creme Medium	OCTINOXATE 7.5%, TITANIUM DIOXIDE 5%, ZINC OXIDE 1%	Melaleuca Inc.	68a4ed34-f492-67a6-e053-2a91aa0a0428	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella Daily UV Defense Broad-Spectrum SPF 25 Sunscreen	SUNSCREEN	Melaleuca Inc.	1f1d1575-cf37-5d66-e063-6394a90ab2a3	2025-12-31	Warnings	Exact identifier application number: M020
Eucerin Daily Hydration	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	Beiersdorf Inc	c9bb7d33-783b-4cbb-a130-91f92d4cc137	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Creme Sheer to Light 140 N	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	a13e5326-73c3-9fa8-e053-2a95a90aae9d	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Creme Sheer to Light 20 N	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	a13e3f45-8e6f-6a3f-e053-2995a90a17d2	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Creme Deep 550 N	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e31a82-0cd0-5a1a-e053-2991aa0a33f8	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Creme Light to Medium 200 N	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e2dfaa-d173-e6a9-e053-2a91aa0a4663	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Creme Medium 300 W	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e2e541-c583-0f12-e053-2991aa0a4ab2	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Creme Medium to Deep 500 W	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e30231-4fba-35d4-e053-2991aa0a33cb	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Creme Medium 440 N	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e30255-5640-3b4a-e053-2991aa0ab3f7	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Creme Medium to Deep 450 W	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e30255-564f-3b4a-e053-2991aa0ab3f7	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Creme Medium 320 C	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e2e541-c596-0f12-e053-2991aa0a4ab2	2025-12-31	Warnings	Exact identifier application number: M020
Sei Bella Tinted BB Moisturizing Creme Light to Medium 160 N	TITANIUM DIOXIDE 5% AND ZINC OXIDE 5%	Melaleuca Inc.	68e20c57-7b30-4e96-e053-2991aa0aab3e	2025-12-31	Warnings	Exact identifier application number: M020
Sun Shades Lip Balm Pina Colada	AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%	Melaleuca Inc.	16d0d2d2-b9c4-4491-8d8a-815843d342e8	2025-12-31	Warnings	Exact identifier application number: M020
Sun Shades Lip Balm Mountain Mint	AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%	Melaleuca Inc.	326d9623-0e67-43bd-83f8-ee7dfa3bdbe8	2025-12-31	Warnings	Exact identifier application number: M020
Sun Shades Lip Balm Vanilla Bean	AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%	Melaleuca Inc.	2037cc9d-b11b-47d6-8d65-c0f9decc8ba7	2025-12-31	Warnings	Exact identifier application number: M020
Sun Shades Mineral Plus Sunscreen with Zinc Oxide	OCTISALATE 5%, OCTOCRYLENE 3%, ZINC OXIDE 10.5%	Melaleuca Inc.	8886cbd0-ed2b-4a2b-a724-a0d4f12296c9	2025-12-31	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
5A68WGF6WM	OCTOCRYLENE	6197-30-4	OCTOCRYLENE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
15FIX9V2JP	TITANIUM DIOXIDE	13463-67-7	TITANIUM DIOXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
84509-002-01	84509000201	30 mL in 1 BOTTLE (84509-002-01)	30 ml	2024-07-16	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Sunscreen Emulsion SPF50plus	Guangzhou Senmai Biotechnology Co. \| Dongguan Xiaogoubeige trading company Ltd.	2025-01-08	HUMAN OTC DRUG LABEL	3