Your browser does not support JavaScript! AMBI SUNSCREEN (AVOBENZONE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [KIK CUSTOM PRODUCTS]
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AMBI SUNSCREEN (avobenzone, octisalate, octocrylene, and oxybenzone) lotion
[KIK Custom Products]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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 Label Sections

Sunscreen Lotion

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

Call 1-800-321-4576

Directions:      For sunscreen use, apply generously and every 15 minutes before sun exposure
                      Use a water resistant sunscreen if swimming or sweating
                      Reapply at least every 2 hours

Sun Protection Measures:

                      Spending time in the sun increases your risk of skin cancer and early skin aging
                      To decrease this risk, regularly use a sunscreen with a broad spectrum SPF value of 15 or higher and other sun protection          measures including limit time in the sun, especially from 10 AM - 2 PM
                      Wear long sleeved shirts, pants, hats and sunglasses
                      Children under 6 months of age ask a Doctor

                      Protect this product from excessive heat and direct sun.
                      May stain some fabric.

Avobenzone 3%
Octisalate  5%
Octocrylene 1.7%
Oxybenzone 3%

Water,

C12-15 Alkyl Benzoate

Dimethicone

Diethylhexyl 2

6-Naphthalate

Glycerin

Arachidyl Alcohol

Phenyl Trimethicone

Sodium Polyacrylate

Silica

PCA Dimethicone

Cetearyl Alcohol

Phenoxyethanol

Methyl Methacrylate

Crosspolymer

Behenyl Alcohol

Aluminum Starch Octenylsuccinate

Steareth - 2

Betaine

Fragrance

Arachidyl Gluccoside

Methylparaben

Steareth - 21

Disodium EDTA

Hydroxypropyl Methylcellulose

Cetearyl Gluccoside

Sodium PCA

Propylparaben

Benzalkonium Chloride

Sorbitol

Ethylparaben

Boron Nitride

Serine

Iodopropynyl Butylcarbonate

Glycine

Glutamic Acid

Alanine

Arginine

Lysine

Theonine

Proline







Label - KK1.jpg

Label

Helps prevent sun burn if use as directed with other sun protection measures (see directions)

Decreases the risk of skin cancer and early skin aging caused by the sun

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 a Doctor if rash occurs.

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


AMBI  SUNSCREEN
avobenzone, octisalate, octocrylene, and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:61047-825
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone1.77 g  in 59 g
Octisalate (Octisalate) Octisalate 2.95 g  in 59 g
Octocrylene (Octocrylene) Octocrylene1.0 g  in 59 g
Oxybenzone (Oxybenzone) Oxybenzone1.77 g  in 59 g
Inactive Ingredients
Ingredient NameStrength
Dimethicone 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61047-825-9559 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35204/09/2013
Labeler - KIK Custom Products (243547333)
Registrant - KIK Operating Partnership (243547333)
Establishment
NameAddressID/FEIBusiness Operations
KIK Custom Products243547333manufacture(61047-825)

Revised: 4/2013
 
KIK Custom Products

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