ORLASKIN HYDRATING SUNSCREEN

Product NDC: 83447-003
Requested package NDC: 83447-003-01
11-digit product format: 834470003
Labeler code: 83447
Product ID: 83447-003_479ede48-5b2e-5407-e063-6394a90aab53
Type: HUMAN OTC DRUG
Nonproprietary name: ORLASKIN HYDRATING SUNSCREEN
Dosage form: SPRAY
Route: CUTANEOUS
Labeler: Guangzhou Fantesy Biotechnology Co.,Ltd
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-10-19
Substance: OCTOCRYLENE; HOMOSALATE; OCTISALATE; AVOBENZONE
Active strength: 8; 10; 5; 3 g/100mL; 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: ORLASKIN HYDRATING SUNSCREEN
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTOCRYLENE	8 g/100mL
HOMOSALATE	10 g/100mL
OCTISALATE	5 g/100mL
AVOBENZONE	3 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
4X49Y0596W	Internal UNII lookup
G63QQF2NOX	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
0808b0cd-2cfb-8554-e063-6294a90ad6c4	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7792dadb-52b6-46b6-8fdf-80b1171065b5	Product name	1	20180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
83447-003-01	ORLASKIN HYDRATING SUNSCREEN	100 mL in 1 BOX	SPRAY	100		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
83447-003	ORLASKIN HYDRATING SUNSCREEN SPRAY [GUANGZHOU FANTESY BIOTECHNOLOGY CO.,LTD]	2	Current NDC, 1 package rows	20240810_0808b0cd-2cfb-8554-e063-6294a90ad6c4.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 92 of 354 · 7,077 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Fair	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4743b6a9-4d79-1b2b-e063-6394a90a9710	2025-12-31	Warnings	Exact identifier application number: M020
Royal Jelly Radiance Foundation Broad Spectrum SPF 20 Earth	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	0edc7bd4-9350-48e1-bbfe-e6450458ae59	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 - Bronze	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	90fbf555-106c-4131-b572-ead9bbb246e6	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 - Honey	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	1accbe67-c722-4af7-8422-0559ac4a987a	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 - Bare	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	5c0805c7-9b92-4c08-877c-64e720308430	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20- Natural	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	0cc5429d-ace4-4060-b993-1b607218eaf8	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20-Nude	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	b1851c5d-32ad-482a-bd24-2f280a68ef9e	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 -Spice	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	6164dc23-81c2-48b8-b309-2c5a81fe13a4	2025-12-31	Warnings	Exact identifier application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Light Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4744e501-f12a-6d25-e063-6394a90a2574	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 - Tawny	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	d7c4e758-3af2-40c6-bbe1-37e6fd0a5eb6	2025-12-31	Warnings	Exact identifier application number: M020
Radiance Foundation Broad Spectrum SPF 20 - Cappuccino	OCTINOXATE, ZINC OXIDE	Distribuidora Comercial Jafra, S.A. de C.V.	30601a73-089e-4fa7-8fb7-6b108498934a	2025-12-31	Warnings	Exact identifier application number: M020
Good Karma Dry Oil Mineral Sunscreen SPF-30	ZINC OXIDE SUNSCREEN	SOLARA SUNCARE, INC.	209c4913-29e6-24ca-e063-6294a90a6872	2025-12-31	Warnings	Exact identifier application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Medium	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	47456bf5-9f6c-e6a5-e063-6294a90a7054	2025-12-31	Warnings	Exact identifier application number: M020
Olay Age Defying Classic Daily Renewal Broad Spectrum SPF 15	OCTINOXATE AND ZINC OXIDE	The Procter & Gamble Manufacturing Company	60183a47-fd02-052b-e053-2991aa0a1b5c	2025-12-31	Warnings	Exact identifier application number: M020
Native Mineral Sunscreen Broad Spectrum SPF 30 Sweet Peach and Nectar	ZINC OXIDE	The Procter & Gamble Manufacturing Company	026dcaee-d33c-b874-e063-6394a90ad2e7	2025-12-31	Warnings	Exact identifier application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4745ab56-abaa-42de-e063-6394a90a6310	2025-12-31	Warnings	Exact identifier application number: M020
Olay Complete Plus Daily Facial Moisturizer with Sunscreen Broad Spectrum SPF 40	AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE	The Procter & Gamble Manufacturing Company	22f645cf-5182-9e3f-e063-6394a90adc84	2025-12-31	Warnings	Exact identifier application number: M020
Native Mineral Sunscreen Broad Spectrum SPF 30 Tropical Breeze	ZINC OXIDE	The Procter & Gamble Manufacturing Company	232032b7-803f-40ec-e063-6394a90a4b38	2025-12-31	Warnings	Exact identifier application number: M020
Coppertone Sport Sunscreen SPF 100	AVOBENZONE 3%, HOMOSALATE 15%, OCTINOXATE 2% OCTISALATE 5%, OCTOCRYLENE 10%, OXYBENZONE 6%	Beiersdorf Inc	e1a9a831-a0b9-17ba-e053-2a95a90a3fa7	2025-12-31	Warnings	Exact identifier application number: M020
Radiant Glow Illuminating BB Cream Sunscreen SPF 30 - Tan Deep	OCTINOXATE, TITANIUM DIOXIDE, ZINC OXIDE	Pur-lisse Beauty, LLC	4745ebec-acb0-77c4-e063-6394a90aee07	2025-12-31	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
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
83447-003-01	83447000301	100 mL in 1 BOX (83447-003-01)	100 ml	2023-10-19	No	No	Current