Soleil Broad Spectrum SPF-50

Product NDC: 69630-003
11-digit product format: 696300003
Labeler code: 69630
Product ID: 69630-003_2f80bdd5-a876-401c-8115-516a085a3a3a
Type: HUMAN OTC DRUG
Nonproprietary name: Octinoxate, Octisalate, Zinc Oxide
Dosage form: SPRAY
Route: TOPICAL
Labeler: The Soleil Group, LLC
Application: part352
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-02-13
Marketing end: 0000-00-00
Substance: OCTINOXATE; OCTISALATE; ZINC OXIDE; AVOBENZONE
Active strength: 8 mg/mL; mg/mL; mg/mL; mg/mL
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	69630-003		I	Inactivated by FDA		2026-10-05
excluded package	package	69630-003	69630-003-50	I	Inactivated by FDA		2026-10-05

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 · 44 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
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69630-003-50	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69630-003-50	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
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	69630-003-50	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	69630-003-50	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	69630-003-50	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	69630-003-50	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69630-003-50	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69630-003-50	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69630-003-50	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69630-003-50	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69630-003-50	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69630-003-50	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69630-003-50	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69630-003-50	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69630-003-50	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	69630-003-50	I	Inactivated by FDA	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	69630-003-50	I	Inactivated by FDA	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	69630-003-50	I	Inactivated by FDA	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	69630-003-50	I	Inactivated by FDA	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	69630-003-50	I	Inactivated by FDA	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	69630-003-50	I	Inactivated by FDA	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	69630-003-50	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69630-003-50	2020-01-31	C162847	48780-1	9d75b9d0-7456-f424-e053-dadaa90a57ce	Soleil SPF-50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69630-003-50	Soleil Broad Spectrum SPF-50	177.4 mL in 1 BOTTLE, SPRAY	SPRAY	177.4		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
ZINC CATION	ACTIVE MOIETY	13S1S8SF37	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
ARTEMISIA PALLENS WHOLE	INACTIVE INGREDIENT	39JKR5IL2G	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
CAPRYLIC/CAPRIC/LINOLEIC TRIGLYCERIDE	INACTIVE INGREDIENT	U73D397055	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
CARROT	INACTIVE INGREDIENT	L56Z1JK48B	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
CETEARYL OLIVATE	INACTIVE INGREDIENT	58B69Q84JO	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
CITRUS AURANTIUM FLOWER OIL	INACTIVE INGREDIENT	D4BGE91OXH	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
CITRUS AURANTIUM FRUIT	INACTIVE INGREDIENT	DQD16J2B5O	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
CITRUS LIMON FRUIT OIL	INACTIVE INGREDIENT	0HNC1J1YED	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
CITRUS NOBILIS	INACTIVE INGREDIENT	8MFF77J91V	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
CITRUS SINENSIS FRUIT OIL	INACTIVE INGREDIENT	WV48LBL15Q	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
ETHYL ACETOACETATE	INACTIVE INGREDIENT	IZP61H3TB1	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
EUCALYPTUS GLOBULUS WHOLE	INACTIVE INGREDIENT	SI1P2XF3M3	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
FUCUS VESICULOSUS	INACTIVE INGREDIENT	535G2ABX9M	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
GLUCONOLACTONE	INACTIVE INGREDIENT	WQ29KQ9POT	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
ISOAMYL ACETATE	INACTIVE INGREDIENT	Z135787824	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
ISOBUTYL ACETATE	INACTIVE INGREDIENT	7CR47FO6LF	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
JASMINUM SAMBAC WHOLE	INACTIVE INGREDIENT	1Z81V275I0	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
LECITHIN, SOYBEAN	INACTIVE INGREDIENT	1DI56QDM62	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
LEVOMENOL	INACTIVE INGREDIENT	24WE03BX2T	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER	INACTIVE INGREDIENT	39DK5WQ2PR	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
OPOPANAX CHIRONIUM WHOLE	INACTIVE INGREDIENT	0LGQ3H5EXR	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
PEG/PPG-17/6 COPOLYMER	INACTIVE INGREDIENT	P5QZM4T259	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
PIPERONAL	INACTIVE INGREDIENT	KE109YAK00	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
POLYSORBATE 20	INACTIVE INGREDIENT	7T1F30V5YH	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
PROPANEDIOL	INACTIVE INGREDIENT	5965N8W85T	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
SALVIA SCLAREA SEED OIL	INACTIVE INGREDIENT	JK0RP5O3HW	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
SODIUM BENZOATE	INACTIVE INGREDIENT	OJ245FE5EU	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
SORBITAN OLIVATE	INACTIVE INGREDIENT	MDL271E3GR	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
TETRAHEXYLDECYL ASCORBATE	INACTIVE INGREDIENT	9LBV3F07AZ	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2
water	INACTIVE INGREDIENT	059QF0KO0R	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69630-003	SOLEIL BROAD SPECTRUM SPF-50 (OCTINOXATE, OCTISALATE, ZINC OXIDE) SPRAY [THE SOLEIL GROUP, LLC]	2	Legacy NDC, 1 package rows	20150227_4fd69e0b-f6b5-49bd-8b0e-534f7487f4d0.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE
G63QQF2NOX	AVOBENZONE	70356-09-1	AVOBENZONE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
69630-003-50	69630000350	177.4 mL in 1 BOTTLE, SPRAY	177.4 ml	Historical