GLOVES IN A BOTTLE WITH SPF15- octinoxate, octisalate, homosalate lotion

Gloves in a Bottle with SPF15 by

Drug Labeling and Warnings

Gloves in a Bottle with SPF15 by is a Otc medication manufactured, distributed, or labeled by Gloves in a Bottle, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Octinoxate  7%

Octisalate  5%

Homosalate  3%

OTC - PURPOSE SECTION

Sunscreen

USES

Helps prevent sunburn.

WARNINGS

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.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

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

DIRECTIONS

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

INACTIVE INGREDIENTS

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

PROTECT THIS PRODUCT FROM EXCESSIVE HEAT AND DIRECT SUN.

QUESTIONS OR COMMENTS?

Call toll free 1-800-600-1881

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

GLOVES IN A BOTTLE WITH SPF15 
octinoxate, octisalate, homosalate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69081-002
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Octinoxate (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	Octinoxate	0.07 g  in 1 g
Octisalate (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	Octisalate	0.05 g  in 1 g
Homosalate (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	Homosalate	0.03 g  in 1 g

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
aloe vera leaf (UNII: ZY81Z83H0X)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
METHYL GLUCETH-20 (UNII: J3QD0LD11P)
COMFREY LEAF (UNII: DG4F8T839X)
MATRICARIA CHAMOMILLA WHOLE (UNII: 2Z4LRR776S)
ACHILLEA MILLEFOLIUM (UNII: 2FXJ6SW4PK)
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SORBITAN MONOOLEATE (UNII: 06XEA2VD56)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
AMINOMETHYLPROPANOL (UNII: LU49E6626Q)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
(C10-C30)ALKYL METHACRYLATE ESTER (UNII: XH2FQZ38D8)
Dimethicone/Vinyl Dimethicone Crosspolymer (Soft Particle) (UNII: 9E4CO0W6C5)
BIS-HYDROXYETHOXYPROPYL DIMETHICONE (37 CST) (UNII: 7K226YI89Y)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69081-002-08	244.94 g in 1 BOTTLE; Type 0: Not a Combination Product	07/07/2014
2	NDC: 69081-002-13	100 g in 1 TUBE; Type 0: Not a Combination Product	02/07/2017
3	NDC: 69081-002-05	5 g in 1 PACKAGE; Type 0: Not a Combination Product	09/27/2019
4	NDC: 69081-002-18	240 g in 1 TUBE; Type 0: Not a Combination Product	02/07/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/07/2014

Labeler - Gloves in a Bottle, Inc (926499054)