Bellagio Childrens Sunscreen SPF 45

Product NDC: 65643-336
11-digit product format: 656430336
Labeler code: 65643
Product ID: 65643-336_7546ca55-e729-47ca-9130-f27f71e32c80
Type: HUMAN OTC DRUG
Nonproprietary name: Homosalate, Octinoxate, Octisalate, Oxybenzone, and Zinc Oxide
Dosage form: LOTION
Route: TOPICAL
Labeler: Lifetech Resources, LLC
Application: part352
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2009-02-01
Marketing end: 0000-00-00
Substance: HOMOSALATE; OCTINOXATE; OCTISALATE; OXYBENZONE; ZINC OXIDE
Active strength: 142 mg/mL; 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

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 · 14 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	65643-336-19	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	65643-336-19	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	65643-336-19	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	65643-336-19	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	65643-336-19	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	65643-336-19	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	65643-336-19	`110d247fa046…`	`a55b01930146…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65643-336-19	2019-10-21	C162847	48780-1	956f9ecf-c2b2-621f-e053-dbdaa90a74ad	BELLAGIO ® CHILDREN'S SUNSCREEN LOTION SPF 45

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Homosalate	ACTIVE INGREDIENT	V06SV4M95S	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Octinoxate	ACTIVE INGREDIENT	4Y5P7MUD51	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Octisalate	ACTIVE INGREDIENT	4X49Y0596W	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Oxybenzone	ACTIVE INGREDIENT	95OOS7VE0Y	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Zinc Oxide	ACTIVE INGREDIENT	SOI2LOH54Z	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Homosalate	ACTIVE MOIETY	V06SV4M95S	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Octinoxate	ACTIVE MOIETY	4Y5P7MUD51	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Octisalate	ACTIVE MOIETY	4X49Y0596W	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Oxybenzone	ACTIVE MOIETY	95OOS7VE0Y	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Zinc Oxide	ACTIVE MOIETY	SOI2LOH54Z	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
.ALPHA.-TOCOPHEROL ACETATE, D-	INACTIVE INGREDIENT	A7E6112E4N	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Aloe Vera Leaf	INACTIVE INGREDIENT	ZY81Z83H0X	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Avocado	INACTIVE INGREDIENT	SDS87L369F	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Calendula Officinalis Flower	INACTIVE INGREDIENT	P0M7O4Y7YD	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Cetostearyl Alcohol	INACTIVE INGREDIENT	2DMT128M1S	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
CHAMOMILE	INACTIVE INGREDIENT	FGL3685T2X	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Cyclomethicone 5	INACTIVE INGREDIENT	0THT5PCI0R	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Imidurea	INACTIVE INGREDIENT	M629807ATL	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Macadamia Oil	INACTIVE INGREDIENT	515610SU8C	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Medium-Chain Triglycerides	INACTIVE INGREDIENT	C9H2L21V7U	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
OCTYLTRIETHOXYSILANE	INACTIVE INGREDIENT	LDC331P08E	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Panthenol	INACTIVE INGREDIENT	WV9CM0O67Z	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
POLYOXYL 20 CETOSTEARYL ETHER	INACTIVE INGREDIENT	YRC528SWUY	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Potassium Cetyl Phosphate	INACTIVE INGREDIENT	03KCY6P7UT	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Potassium Sorbate	INACTIVE INGREDIENT	1VPU26JZZ4	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Shea Butter	INACTIVE INGREDIENT	K49155WL9Y	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Sodium Benzoate	INACTIVE INGREDIENT	OJ245FE5EU	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Sodium Pyrrolidone Carboxylate	INACTIVE INGREDIENT	469OTG57A2	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Sorbitan Monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1
Xanthan Gum	INACTIVE INGREDIENT	TTV12P4NEE	BELLAGIO CHILDRENS SUNSCREEN SPF 45 (HOMOSALATE, OCTINOXATE, OCTISALATE, OXYBENZONE, AND ZINC OXIDE) LOTION [LIFETECH RESOURCES, LLC]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
V06SV4M95S	HOMOSALATE	118-56-9	HOMOSALATE
4Y5P7MUD51	OCTINOXATE	83834-59-7	OCTINOXATE
4X49Y0596W	OCTISALATE	118-60-5	OCTISALATE
95OOS7VE0Y	OXYBENZONE	131-57-7	OXYBENZONE
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
BELLAGIO ® CHILDREN'S SUNSCREEN LOTION SPF 45	Lifetech Resources, LLC	2010-09-13	HUMAN OTC DRUG LABEL	1

Bellagio Childrens Sunscreen SPF 45

Observed NDC auxiliary status history#

Reported adverse events (FAERS/openFDA)#

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Related Records#

Related UNII Ingredients#

Related DailyMed Labels#