Tinted Moisturizer SPF20 Dark

Dosage form: cream
Ingredients: OCTINOXATE 0.05g in 1g, TITANIUM DIOXIDE 0.042g in 1g
Labeler: CBI Laboratories, Inc
NDC Code: 24623-049

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.

skin-perfecting
tinted moisturizer
SPF 20
SUNCARE
ESSENTIALS
dark

Drug Facts

Active ingredientsPurpose
Octinoxate 5%sunscreen
Titanium Dioxide 4.2%sunscreen

Uses
  • provides moderate sun protection

Warnings
  • for external use only
  • for adult use only

When using this product

  • keep out of eyes. If contact occurs rinse with water to remove.

  • Stop use if irritation occurs.

  • Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions
  • Apply liberally 20 minutes before sun exposure and reapply as needed.
  • Children under 6 months of age: ask a physician.

Inactive ingredients

Aluminum Hydroxide, Aluminum Starch Octenylsuccinate, C12-15 Alkyl Benzoate, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Chlorphenesin, Cyclopentasiloxane, Disodium EDTA, Ethylhexyl Stearate, Hexyl Laurate, Hydrogenated Castor Wax, Iron Oxides (CI 77492,77491, 77499), Magnesium Sulfate, Microcrystalline Wax, Polyglyceryl-4 Diisostearate, Polyglyceryl-4 Isostearate, Polyhydroxystearate Sebacate, Polyglyceryl-3 Polydimethylsiloxyethyl Dimethicone, Stearic Acid, Titanium Dioxide (CI 77891), Triethoxysilylethyl Polydimethylsiloxyethyl Hexyl Dimethicone, Water (Aqua)

PRINCIPAL DISPLAY PANEL - 48.2 g Carton

skin-perfecting
tinted moisturizer

SPF 20

SUNCARE
ESSENTIALS

dark

Net Wt. 1.7 Oz / 48.2 g

TINTED MOISTURIZER SPF20   DARK
octinoxate and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:24623-049
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE0.05 g  in 1 g
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE0.042 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
POLYGLYCERYL-4 ISOSTEARATE 
ETHYLHEXYL STEARATE 
WATER 
CYCLOMETHICONE 
C12-15 ALKYL BENZOATE 
HYDROGENATED CASTOR OIL 
MICROCRYSTALLINE WAX 
FERRIC OXIDE RED 
FERROSOFERRIC OXIDE 
FERRIC OXIDE YELLOW 
CHLORPHENESIN 
MAGNESIUM SULFATE, UNSPECIFIED 
EDETATE DISODIUM 
STEARIC ACID 
Packaging
#Item CodePackage Description
1NDC:24623-049-1748.2 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart35204/01/2007
Labeler - CBI Laboratories, Inc (623704368)
Establishment
NameAddressID/FEIOperations
CBI Laboratories, Inc.623704368MANUFACTURE

Revised: 01/2011
 
CBI Laboratories, Inc

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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