SKINDOG - avobenzone,octocrylene,oxybenzone,homosalate,octisalate lotion 
SkinDog, LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients:                                                                                                   Purpose
Avobenzone 3.0%...................................................................................................Sunscreen (A)
Octocrylene  4.0%...................................................................................................Sunscreen (B)
Oxybenzone 6.0%...................................................................................................Suncreeen (A)
Homosalate  15.0%.................................................................................................Sunscreen (B)
Octisalate     5.0%...................................................................................................Sunscreen (B)


Uses

Warnings

For External use only
UV exposure from the sun increases the risk of skin cancer, premature skin aging, and other skin damage. It is important to decrease UV exposure by limiting time in the sun, wearing protective clothing, and using sunscreen.

Directions

Inactive Ingredients

Aqua; Acrylates/C10-30 Alkyl Acrylate Crosspolymer; Sorbitol; Marshmellow Extract,; Ivy Extract; Cucumber Extract; Elder Flower; Arnica Extract; EDTA; Aloe Barbadensis Leaf Juice; Isopropyl Palmitate; Stearic Acid; PEG100 Stearate; Dimethicone;  Cetyl Alcohol; Glyceryl Stearate; C12-15 Alkyl Benzoate; Cetearyl Alcohol, Ceteareth-20; Phenoxyethanol Ethylhexyl Glycerin; Triethanolamine; Tetrasodium EDTA; Tocopheryl Acetate

image of tube label


When using this product keep out of eyes.

Rinse with water to remove.

May stain some fabrics

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Stop use and ask a doctor if skin rash occurs.

SKINDOG 
avobenzone,octocrylene,oxybenzone,homosalate,octisalate lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42657-111
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone1.70 g  in 56.7 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S) Homosalate8.5 g  in 56.7 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone3.4 g  in 56.7 g
Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate2.8 g  in 56.7 g
Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene2.27 g  in 56.7 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
SORBITOL (UNII: 506T60A25R)  
Isopropyl Palmitate (UNII: 8CRQ2TH63M)  
C12-15 ALKYL BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERYL DISTEARATE (UNII: 73071MW2KM)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
CETYL ALCOHOL (UNII: 936JST6JCN)  
POLYOXYL 100 STEARATE (UNII: YD01N1999R)  
CARBOMER COPOLYMER TYPE A (UNII: 71DD5V995L)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Dimethicone (UNII: 92RU3N3Y1O)  
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
CUCUMBER (UNII: YY7C30VXJT)  
HEDERA HELIX LEAF (UNII: ZP9XFG71A7)  
ALTHAEA OFFICINALIS ROOT (UNII: TRW2FUF47H)  
EDETATE SODIUM (UNII: MP1J8420LU)  
TROLAMINE (UNII: 9O3K93S3TK)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42657-111-0156.7 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35201/05/2012
Labeler - SkinDog, LLC (078352090)

Revised: 1/2012
Document Id: d7589450-bec8-4796-bc91-aa096017870e
Set id: f63fe245-8396-477d-83af-66e5f4f7ceba
Version: 5
Effective Time: 20120105
 
SkinDog, LLC