Gloves in a Bottle with SPF15

Product NDC
69081-002
Requested package NDC
69081-002-18
11-digit product format
690810002
Labeler code
69081
Product ID
69081-002_f0ff6396-2da0-295d-e053-2995a90a6d1c
Type
HUMAN OTC DRUG
Nonproprietary name
Octinoxate, octisalate, homosalate
Dosage form
LOTION
Route
TOPICAL
Labeler
Gloves in a Bottle, Inc
Application
part352
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-07-07
Marketing end
0000-00-00
Substance
HOMOSALATE; OCTINOXATE; OCTISALATE
Active strength
0 g/g; g/g; g/g
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69081-00269081-002-18DDiscontinued by firm2026-10-05

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 · 4 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2021-12-27 23:28 UTC · source 2021-12-27IInactivated by FDA8dfbde2a14a4…c9ff85d89658…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HomosalateACTIVE INGREDIENTV06SV4M95SGLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
OctinoxateACTIVE INGREDIENT4Y5P7MUD51GLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
OctisalateACTIVE INGREDIENT4X49Y0596WGLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
HOMOSALATEACTIVE MOIETYV06SV4M95SGLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
OCTINOXATEACTIVE MOIETY4Y5P7MUD51GLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
OCTISALATEACTIVE MOIETY4X49Y0596WGLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
(C10-C30)ALKYL METHACRYLATE ESTERINACTIVE INGREDIENTXH2FQZ38D8GLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
1,2-HEXANEDIOLINACTIVE INGREDIENTTR046Y3K1GGLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
ACHILLEA MILLEFOLIUMINACTIVE INGREDIENT2FXJ6SW4PKGLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0XGLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L0GLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
AMINOMETHYLPROPANOLINACTIVE INGREDIENTLU49E6626QGLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST)INACTIVE INGREDIENT7K226YI89YGLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RAGLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438UGLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
CHONDRUS CRISPUS CARRAGEENANINACTIVE INGREDIENTUE856F2T78GLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
COMFREY LEAFINACTIVE INGREDIENTDG4F8T839XGLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RGLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OGLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle)INACTIVE INGREDIENT9E4CO0W6C5GLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
MATRICARIA CHAMOMILLA WHOLEINACTIVE INGREDIENT2Z4LRR776SGLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
METHYL GLUCETH-20INACTIVE INGREDIENTJ3QD0LD11PGLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TGLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD56GLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1
waterINACTIVE INGREDIENT059QF0KO0RGLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69081-002GLOVES IN A BOTTLE WITH SPF15 (OCTINOXATE, OCTISALATE, HOMOSALATE) LOTION [GLOVES IN A BOTTLE, INC]11Legacy NDC20250130_aef92fed-3a25-4617-8634-3250524c0945.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69081-002-1869081000218240 g in 1 TUBE (69081-002-18) 240 g2017-02-070000-00-00NoNoCurrent