FDA.reportPublic FDA data

Gloves in a Bottle with SPF15

Manufacturer
Gloves in a Bottle, Inc
Effective date
2025-11-13
Label type
HUMAN OTC DRUG LABEL
Version
12
Source
monthly-update
Hydrated at
2026-06-03 17:40:09

Label at a glance#

ProductGloves in a Bottle with SPF15
Active ingredientOCTINOXATE, OCTISALATE, HOMOSALATE
Label structure10 sections

Indications and uses

Helps prevent sunburn.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.

Storage and handling

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Octinoxate  7%

Octisalate  5%

Homosalate  3%

OTC - PURPOSE SECTION

Sunscreen

USES

INDICATIONS & USAGE SECTION

Helps prevent sunburn.

WARNINGS

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

For external use only.

Do not use on damaged or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN.

If product is swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply at least every 2 hours.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Water (Aqua), Aloe Vera Leaf Extract , Cyclopentasiloxane, Dimethicone, Methyl Gluceth-20, Symphytum Officinale Leaf (Comfrey), Chamomilla Recutita (Matricaria Chamomile), Achillea Millefolium (Yarrow), Chondrus Crispus (Carrageenan), Tocopheryl Acetate (Vitamin E), Sorbitan Monoleate, 1,2 Hexanediol, Caprylyl Gylcol, Butylene Glycol, Aminomethyl Propanol, Phenoxyethanol (preservative), Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Dimethicone/Vinyl Dimethicone Crosspolymer, Bis-Hydroxyethoxypropyl Dimethicone.

OTHER INFORMATION

STORAGE AND HANDLING SECTION

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call toll free 1-800-600-1881

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

8 oz GIAB spf yellow_pr48 oz GIAB spf yellow_pr4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130733620800148GTIN-13: 0733620800148
EAN-13: 0733620800148
GTIN-12: 733620800148
UPC-A: 733620800148
GTIN storage (14 digits): 00733620800148		8 oz GIAB spf yellow_pr4.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69081-002-052021-12-31C16284748780-1c7ccaba7-23dc-fd44-e053-dadaa90aa01bGLOVES IN A BOTTLE - SPF15 (69081-002) DELIST
69081-002-082021-12-31C16284748780-1c7ccaba7-23dc-fd44-e053-dadaa90aa01bGLOVES IN A BOTTLE - SPF15 (69081-002) DELIST
69081-002-132021-12-31C16284748780-1c7ccaba7-23dc-fd44-e053-dadaa90aa01bGLOVES IN A BOTTLE - SPF15 (69081-002) DELIST
69081-002-182021-12-31C16284748780-1c7ccaba7-23dc-fd44-e053-dadaa90aa01bGLOVES IN A BOTTLE - SPF15 (69081-002) DELIST
69081-002-052021-07-23C16284748780-1c7ccaba7-23dc-fd44-e053-dadaa90aa01bGLOVES IN A BOTTLE - SPF15 (69081-002) DELIST
69081-002-082021-07-23C16284748780-1c7ccaba7-23dc-fd44-e053-dadaa90aa01bGLOVES IN A BOTTLE - SPF15 (69081-002) DELIST
69081-002-132021-07-23C16284748780-1c7ccaba7-23dc-fd44-e053-dadaa90aa01bGLOVES IN A BOTTLE - SPF15 (69081-002) DELIST
69081-002-182021-07-23C16284748780-1c7ccaba7-23dc-fd44-e053-dadaa90aa01bGLOVES IN A BOTTLE - SPF15 (69081-002) DELIST

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HomosalateACTIVE INGREDIENTV06SV4M95S1
OctinoxateACTIVE INGREDIENT4Y5P7MUD511
OctisalateACTIVE INGREDIENT4X49Y0596W1
HOMOSALATEACTIVE MOIETYV06SV4M95S1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OCTISALATEACTIVE MOIETY4X49Y0596W1
(C10-C30)ALKYL METHACRYLATE ESTERINACTIVE INGREDIENTXH2FQZ38D81
1,2-HEXANEDIOLINACTIVE INGREDIENTTR046Y3K1G1
ACHILLEA MILLEFOLIUMINACTIVE INGREDIENT2FXJ6SW4PK1
aloe vera leafINACTIVE INGREDIENTZY81Z83H0X1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
AMINOMETHYLPROPANOLINACTIVE INGREDIENTLU49E6626Q1
BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST)INACTIVE INGREDIENT7K226YI89Y1
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA1
CAPRYLYL GLYCOLINACTIVE INGREDIENT00YIU5438U1
CHONDRUS CRISPUS CARRAGEENANINACTIVE INGREDIENTUE856F2T781
COMFREY LEAFINACTIVE INGREDIENTDG4F8T839X1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle)INACTIVE INGREDIENT9E4CO0W6C51
MATRICARIA CHAMOMILLA WHOLEINACTIVE INGREDIENT2Z4LRR776S1
METHYL GLUCETH-20INACTIVE INGREDIENTJ3QD0LD11P1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
SORBITAN MONOOLEATEINACTIVE INGREDIENT06XEA2VD561
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 24 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69081-00269081-002-08, 69081-002-13, 69081-002-05, 69081-002-18

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALOE VERA LEAFZY81Z83H0XIACT
CYCLOMETHICONE 50THT5PCI0RIACT
DIMETHICONE92RU3N3Y1OIACT
METHYL GLUCETH-20J3QD0LD11PIACT
COMFREY LEAFDG4F8T839XIACT
MATRICARIA CHAMOMILLA WHOLEG0R4UBI2ZZIACT
ACHILLEA MILLEFOLIUM2FXJ6SW4PKIACT
CHONDRUS CRISPUS CARRAGEENANUE856F2T78IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
SORBITAN MONOOLEATE06XEA2VD56IACT
1,2-HEXANEDIOLTR046Y3K1GIACT
CAPRYLYL GLYCOL00YIU5438UIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
AMINOMETHYLPROPANOLLU49E6626QIACT
PHENOXYETHANOLHIE492ZZ3TIACT
(C10-C30)ALKYL METHACRYLATE ESTERXH2FQZ38D8IACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST)7K226YI89YIACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
HOMOSALATEV06SV4M95SACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 33 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM, AUGMENTED / TOPICAL10 mgExact identifier — unii candidate
6 equally ranked IID candidates
AMINOMETHYLPROPANOLAMINOMETHYLPROPANOLLU49E6626QCREAM / TOPICAL1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56SYSTEM / TRANSDERMAL2.33 mgExact identifier — unii candidate
16 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56TABLET, FILM COATED, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
16 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56TABLET / ORAL19 mgExact identifier — unii candidate
16 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56OINTMENT / TOPICALNAExact identifier — unii candidate
16 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TOPICAL1400 mgExact identifier — unii candidate
2 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56LOTION / TOPICAL7 mgExact identifier — unii candidate
16 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56CAPSULE / ORAL288 mgExact identifier — unii candidate
16 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL / TOPICAL2.5 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL, FOAM / TOPICAL72 mgExact identifier — unii candidate
6 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0FILM / BUCCAL0.09 mgExact identifier — unii candidate
3 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii candidate
3 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56TABLET, FILM COATED / ORAL12 mgExact identifier — unii candidate
16 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56EMULSION / TOPICAL34050 mgExact identifier — unii candidate
16 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56TABLET, COATED / ORAL0.13 mgExact identifier — unii candidate
16 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56FILM, EXTENDED RELEASE / TRANSDERMALNAExact identifier — unii candidate
16 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56GEL / TOPICAL20 mgExact identifier — unii candidate
16 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56SUPPOSITORY / RECTAL390 mgExact identifier — unii candidate
16 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii candidate
3 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56SPRAY / TOPICAL8 mgExact identifier — unii candidate
16 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56TABLET, DELAYED RELEASE / ORAL4 mgExact identifier — unii candidate
16 equally ranked IID candidates
METHYL GLUCETH-20METHYL GLUCETH-20J3QD0LD11PCREAM / TOPICAL5 %w/wExact identifier — unii candidate
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56CREAM / TOPICAL11000 mgExact identifier — unii candidate
16 equally ranked IID candidates
AMINOMETHYLPROPANOLAMINOMETHYLPROPANOLLU49E6626QLOTION / TOPICAL0.3 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
SORBITAN MONOOLEATESORBITAN MONOOLEATE06XEA2VD56SOLUTION / ORAL1080 mgExact identifier — unii candidate
16 equally ranked IID candidates

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
43849b06-7fb0-c4bb-e063-6294a90aa398aef92fed-3a25-4617-8634-3250524c09452025-11-13WarningsExact identifier
spl id: 43849b06-7fb0-c4bb-e063-6294a90aa398
spl set id: aef92fed-3a25-4617-8634-3250524c0945

Reported adverse events (FAERS/openFDA)#

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