GR BB SPF 25

Product NDC: 82715-101
11-digit product format: 827150101
Labeler code: 82715
Product ID: 82715-101_b54c15d7-af7d-42a2-86f4-535bda567692
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate, Oxybenzone, Titanium Dioxide
Dosage form: CREAM
Route: TOPICAL
Labeler: ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI
Application: M020
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2022-06-06
Marketing end: 2029-06-30
Substance: OCTINOXATE; OXYBENZONE; TITANIUM DIOXIDE
Active strength: 2.5; .25; 4.95 g/100mL; g/100mL; g/100mL
NDC exclude flag: No
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 49 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	82715-101-06	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	82715-101-04	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	82715-101-01	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	82715-101-02	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	82715-101-05	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	82715-101-03	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	82715-101-06	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	82715-101-04	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	82715-101-01	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	82715-101-02	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	82715-101-05	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	82715-101-03	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	82715-101-06	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	82715-101-04	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	82715-101-01	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	82715-101-02	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	82715-101-05	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	82715-101-03	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	82715-101-06	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	82715-101-04	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	82715-101-01	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	82715-101-02	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	82715-101-05	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	82715-101-03	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	82715-101-03	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	82715-101-02	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	82715-101-05	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	82715-101-01	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	82715-101-06	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	82715-101-04	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	82715-101-03	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	82715-101-02	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	82715-101-05	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	82715-101-01	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	82715-101-06	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	82715-101-04	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	82715-101-03	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	82715-101-02	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	82715-101-05	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	82715-101-01	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	82715-101-06	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	82715-101-04	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`

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: GR BB SPF 25

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
OCTINOXATE	2.5 g/100mL
OXYBENZONE	.25 g/100mL
TITANIUM DIOXIDE	4.95 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4Y5P7MUD51	Internal UNII lookup
95OOS7VE0Y	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
3b22579b-21ce-4b96-bd24-774ce35bf6f7	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
82715-101-01	2025-08-12	GR GOLDEN ROSE BB CREAM BEAUTY BALM
82715-101-02	2025-08-12	GR GOLDEN ROSE BB CREAM BEAUTY BALM
82715-101-03	2025-08-12	GR GOLDEN ROSE BB CREAM BEAUTY BALM
82715-101-04	2025-08-12	GR GOLDEN ROSE BB CREAM BEAUTY BALM
82715-101-05	2025-08-12	GR GOLDEN ROSE BB CREAM BEAUTY BALM
82715-101-06	2025-08-12	GR GOLDEN ROSE BB CREAM BEAUTY BALM
82715-101-01	2025-01-30	GR GOLDEN ROSE BB CREAM BEAUTY BALM
82715-101-02	2025-01-30	GR GOLDEN ROSE BB CREAM BEAUTY BALM
82715-101-03	2025-01-30	GR GOLDEN ROSE BB CREAM BEAUTY BALM
82715-101-04	2025-01-30	GR GOLDEN ROSE BB CREAM BEAUTY BALM
82715-101-05	2025-01-30	GR GOLDEN ROSE BB CREAM BEAUTY BALM
82715-101-06	2025-01-30	GR GOLDEN ROSE BB CREAM BEAUTY BALM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
82715-101-01	GR BB SPF 25	1 in 1 CARTON	CREAM	1	2
82715-101-01	GR BB SPF 25	30 mL in 1 TUBE	CREAM	30	2
82715-101-02	GR BB SPF 25	1 in 1 CARTON	CREAM	1	2
82715-101-02	GR BB SPF 25	30 mL in 1 TUBE	CREAM	30	2
82715-101-03	GR BB SPF 25	1 in 1 CARTON	CREAM	1	2
82715-101-03	GR BB SPF 25	30 mL in 1 TUBE	CREAM	30	2
82715-101-04	GR BB SPF 25	1 in 1 CARTON	CREAM	1	2
82715-101-04	GR BB SPF 25	30 mL in 1 TUBE	CREAM	30	2
82715-101-05	GR BB SPF 25	30 mL in 1 TUBE	CREAM	30	2
82715-101-05	GR BB SPF 25	1 in 1 CARTON	CREAM	1	2
82715-101-06	GR BB SPF 25	30 mL in 1 TUBE	CREAM	30	2
82715-101-06	GR BB SPF 25	1 in 1 CARTON	CREAM	1	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82715-101	GR BB SPF 25 (OCTINOXATE, OXYBENZONE, TITANIUM DIOXIDE) CREAM [ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI]	1	Current NDC, Legacy NDC, 12 package rows	20220616_3b22579b-21ce-4b96-bd24-774ce35bf6f7.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 224 of 353 · 7,041 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Neutrogena pure and free baby SUNSCREEN Broad Spectrum SPF 50	ZINC OXIDE	Kenvue Brands LLC	2d2c58e2-0d15-4383-adae-12fc17b8ea50	2025-03-20	Warnings	Exact identifier application number: M020
Neutrogena Ultra Sheer Face and Body Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Kenvue Brands LLC	1907126c-fd95-86e8-e063-6394a90a23ca	2025-03-20	Warnings	Exact identifier application number: M020
Neutrogena Sheer Zinc Kids Mineral Sunscreen Broad Spectrum SPF 50 Plus	ZINC OXIDE	Kenvue Brands LLC	4504a10d-6130-4ec5-823a-ab970709e6d7	2025-03-20	Warnings	Exact identifier application number: M020
Vertra Mineral Sunscreen Broad Spectrum SPF 50	ZINC OXIDE	Eai-jr 286, Inc	30caf1dd-142d-85d3-e063-6394a90a0c88	2025-03-20	Warnings	Exact identifier application number: M020
Sun Shades Lip Balm Cranberry Tangerine	AVOBENZONE 2.5%, OCTINOXATE 6%, OXYBENZONE 3%	Melaleuca Inc.	f39606be-19c8-58d1-e053-2a95a90a908f	2025-03-20	Warnings	Exact identifier application number: M020
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 15)	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	aa937596-2378-469f-a0e1-9700044e83b3	2025-03-20	Warnings	Exact identifier application number: M020
Obagi Medical Way to Glow Kit	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	f6f6e219-4ef6-be3b-e053-6294a90a660d	2025-03-20	Warnings	Exact identifier application number: M020
Obagi Medical Back to Basics (Including Obagi Medical Professional-C Serum 20)	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	e8d19915-8996-42df-a47b-2ce00d2bbe68	2025-03-20	Warnings	Exact identifier application number: M020
SHISEIDO URBAN ENVIRONMENT Oil-Free SUNSCREEN SPF 42	ENSULIZOLE, HOMOSALATE, OCTISALATE, AND ZINC OXIDE	SHISEIDO AMERICAS CORPORATION	21bde283-a554-45c8-8733-2a8adeff41b1	2025-03-20	Warnings	Exact identifier application number: M020
SHISEIDO ULTIMATE SUN PROTECTOR	OCTISALATE, HOMOSALATE, OCTOCRYLENE, AND AVOBENZONE	SHISEIDO AMERICAS CORPORATION	7a98171f-bf21-40d4-bc78-883aa0b0c438	2025-03-20	Warnings	Exact identifier application number: M020
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	5e2d7c94-d70a-47e4-9a4b-5953fe38ede2	2025-03-19	Warnings	Exact identifier application number: M020
Carmex Variety Pack Daily Care Sticks Moisturizing Lip Balm SPF 15	OCTINOXATE, OXYBENZONE	Carma Laboratories, Inc.	50206f9e-2dd5-494f-9eed-f7d7ea6efda9	2025-03-18	Warnings	Exact identifier application number: M020
Hello Sun Silky Glow Broad Spectrum SPF40	ZINC OXIDE	The Creme Shop	30a4280b-4a9f-4c18-e063-6394a90a85e6	2025-03-18	Warnings	Exact identifier application number: M020
Vertra Invisible Sunscreen Face Stick Broad Spectrum SPF 45	ZINC OXIDE	Eai-jr 286, Inc	30a5ec14-63d7-e678-e063-6294a90abb57	2025-03-18	Warnings	Exact identifier application number: M020
EXTRASHADE Daily Defense Hydrating Sunscreen SPF 30	AVOBENZONE, OCTINOXATE, OCTISALATE, OXYBENZONE	Extra Shade, LLC	d197dfe3-c754-4a3d-9edd-335f3fce105c	2025-03-18	Warnings	Exact identifier application number: M020
Lancome Paris UV Expert Aquagel Defense 50 Plus Sunscreen Broad Spectrum SPF 50 Plus Primer and Moisturizer	AVOBENZONE, HOMOSALATE, OCTISALATE AND OCTOCRYLENE	L'Oreal USA Products Inc	c88e44da-0b0e-4744-8b4b-4d9d418f29d7	2025-03-18	Warnings	Exact identifier application number: M020
MDP UV BIO SUNSCREEN	ZINC OXIDE, HOMOSALATE, OCTOCRYLENE, OCTISALATE	SKINIDEA CO., LTD	3087771e-2ab8-2198-e063-6294a90a37d4	2025-03-17	Warnings	Exact identifier application number: M020
belif Dew guard - milky sun serum Broad Spectrum SPF 40 sunscreen	AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE	LG H&H CO., LTD.	2b38da59-b83e-4285-e063-6294a90ac6a7	2025-03-17	Warnings	Exact identifier application number: M020
SUN SHIELD BROAD SPECTRUM SPF 50 MATTE SUNSCREEN	HOMOSALATE, OCTISALATE, AND ZINC OXIDE	Obagi Cosmeceuticals LLC	263ef8e8-e0c4-42e6-bb26-7581a437b35a	2025-03-14	Warnings	Exact identifier application number: M020
Impact Melanoma SPF 30	ZINC OXIDE	RENU LABORATORIES, LLC	f953302e-f712-129a-e053-6294a90ab9a8	2025-03-13	Warnings	Exact identifier application number: M020

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE
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	Marketing end	Sample	Exclude flag	Status
82715-101-01	82715010101	1 TUBE in 1 CARTON (82715-101-01) / 30 mL in 1 TUBE	1 tube	2022-06-06	2029-06-30	No	No	Current
82715-101-02	82715010102	1 TUBE in 1 CARTON (82715-101-02) / 30 mL in 1 TUBE	1 tube	2022-06-06	2029-06-30	No	No	Current
82715-101-03	82715010103	1 TUBE in 1 CARTON (82715-101-03) / 30 mL in 1 TUBE	1 tube	2022-06-06	2029-06-30	No	No	Current
82715-101-04	82715010104	1 TUBE in 1 CARTON (82715-101-04) / 30 mL in 1 TUBE	1 tube	2022-06-06	2029-06-30	No	No	Current
82715-101-05	82715010105	1 TUBE in 1 CARTON (82715-101-05) / 30 mL in 1 TUBE	1 tube	2022-06-06	2029-06-30	No	No	Current
82715-101-06	82715010106	1 TUBE in 1 CARTON (82715-101-06) / 30 mL in 1 TUBE	1 tube	2022-06-06	2029-06-30	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
GR GOLDEN ROSE BB CREAM BEAUTY BALM	ERKUL KOZMETIK SANAYI VE TICARET ANONIM SIRKETI	2025-08-06	HUMAN OTC DRUG LABEL	2