SKINNIES SPF30 SUNGEL- sunscreen gel

Skinnies SPF30 Sungel by

Drug Labeling and Warnings

Skinnies SPF30 Sungel by is a Otc medication manufactured, distributed, or labeled by Skinnies USA, Inc., Swiss-American CDMO, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Warnings

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.  Stope use and ask a doctor if rash occurs.  Keep out of reach of children.  If swallowed, get medical help or contact a poison control center right away.

Uses

Helps prevent sunburn, if used as directed with other sun protection meausres (see directions).  Decreases the risk of skin cancer and early skin aging caused by the sun.

Keep out of reach of children

Keep out of reach of children.

Active Ingredients

Avobenzone   3%

Homosalate   15%

Octisalate      3%

Octocrylene   10%

Inactive Ingredients

bentonite, butyloctyl salicylate, coco-caprylate/caprate, dicaprylyl carbonate, diisopropyl adipate, isopropyl palmitate, polytetrafluoroethylene, propylene carbonate, silica, stearalkonium hectorite, tocopheryl acetate, triacontanyl PVP.

Questions

Questions Visit gotskinnies.com

Package label

INGREDIENTS AND APPEARANCE

SKINNIES SPF30 SUNGEL 
sunscreen gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 72454-0030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	100 g  in 1000 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	30 g  in 1000 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	150 g  in 1000 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	30 g  in 1000 g

Inactive Ingredients
Ingredient Name	Strength
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
DIISOPROPYL ADIPATE (UNII: P7E6YFV72X)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
TRIACONTANYL PVP (WP-660) (UNII: N0SS3Q238D)
DICAPRYLYL CARBONATE (UNII: 609A3V1SUA)
STEARALKONIUM HECTORITE (UNII: OLX698AH5P)
BENTONITE (UNII: A3N5ZCN45C)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
POLYTETRAFLUOROETHYLENE (UNII: E1NC1JVS3O)
PROPYLENE CARBONATE (UNII: 8D08K3S51E)
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)

Product Characteristics
Color	brown (light tan)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 72454-0030-1	99 g in 1 TUBE; Type 0: Not a Combination Product	07/18/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/18/2018

Labeler - Skinnies USA, Inc. (115130802)

Registrant - Swiss-American CDMO, LLC (080170933)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO, LLC		080170933	manufacture(72454-0030)