SkinDog

Dosage form: lotion
Ingredients: Avobenzone 1.70g in 56.7g, Homosalate 8.5g in 56.7g, Oxybenzone 3.4g in 56.7g, Octisalate 2.8g in 56.7g, Octocrylene 2.27g in 56.7g
Labeler: SkinDog, LLC
NDC Code: 42657-111

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.

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
  • High UVB sunburn/UVA protection
  • for skin highly sensitive to sunburn
  • retains SPF after 80 minutes of activity

WarningsFor 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
  • Apply liberally before sun exposure.
  • Apply and reapply as directed to avoid lowering protection.
  • Reapply after 80 minutes of swimming or sweating and after towel drying. Otherwise reapply at least every 2 hours.
  • Children under 6 months; ask a doctor.

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



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 AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone1.70 g  in 56.7 g
Homosalate (Homosalate) Homosalate8.5 g  in 56.7 g
Oxybenzone (Oxybenzone) Oxybenzone3.4 g  in 56.7 g
Octisalate (Octisalate) Octisalate2.8 g  in 56.7 g
Octocrylene (Octocrylene) Octocrylene2.27 g  in 56.7 g
Inactive Ingredients
Ingredient NameStrength
Water 
SORBITOL 
Isopropyl Palmitate 
C12-15 ALKYL BENZOATE 
GLYCERYL DISTEARATE 
STEARIC ACID 
ALKYL (C12-15) BENZOATE 
CETYL ALCOHOL 
POLYOXYL 100 STEARATE 
CARBOMER COPOLYMER TYPE A 
ALOE VERA LEAF 
Dimethicone 
ALPHA-TOCOPHEROL ACETATE 
CETOSTEARYL ALCOHOL 
POLYOXYL 20 CETOSTEARYL ETHER 
CUCUMBER 
HEDERA HELIX LEAF 
ALTHAEA OFFICINALIS ROOT 
EDETATE SODIUM 
TROLAMINE 
Packaging
#Item CodePackage Description
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: 01/2012
 
SkinDog, LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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