Label: AMBI SUNSCREEN- avobenzone, octisalate, octocrylene, and oxybenzone lotion
- NDC Code(s): 61047-825-95
- Packager: KIK Custom Products
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated April 9, 2013
If you are a consumer or patient please visit this version.
- KEEP OUT OF REACH OF CHILDREN
If product is swallowed, get medical help or contact a Poison Control Center right away.Close
- DOSAGE & ADMINISTRATION
Directions: For sunscreen use, apply generously and every 15 minutes before sun exposureClose
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.
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
C12-15 Alkyl Benzoate
Aluminum Starch Octenylsuccinate
Steareth - 2
Steareth - 21
- Label - KK1.jpg
- INDICATIONS & USAGE
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 sunClose
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.
- INGREDIENTS AND APPEARANCE
avobenzone, octisalate, octocrylene, and oxybenzone lotion
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61047-825 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX) Avobenzone 1.77 g in 59 g Octisalate (UNII: 4X49Y0596W) (Octisalate - UNII:4X49Y0596W) Octisalate 2.95 g in 59 g Octocrylene (UNII: 5A68WGF6WM) (Octocrylene - UNII:5A68WGF6WM) Octocrylene 1.0 g in 59 g Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y) Oxybenzone 1.77 g in 59 g Inactive Ingredients Ingredient Name Strength Dimethicone (UNII: 92RU3N3Y1O) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61047-825-95 59 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 04/09/2013 Labeler - KIK Custom Products (243547333) Registrant - KIK Operating Partnership (243547333) Establishment Name Address ID/FEI Business Operations KIK Custom Products 243547333 manufacture(61047-825)