Primer Results Tinted Moisturizer SPF15 Caramel

Dosage form: cream
Ingredients: OCTINOXATE 6mL in 100mL, OCTISALATE 4mL in 100mL, TITANIUM DIOXIDE 2.7mL in 100mL
Labeler: Fusion Brands
NDC Code: 51327-210

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.

Primer Results Tinted Moisturizer SPF 15 Caramel

Active Ingredients

Octinoxate 6%
Octisalate   4%
Titanium Dioxide 2.7%

Purpose

Sunscreen

Inactive Ingredients

Dimethicone, Water, Isododecane, Hydrogenated Didecene, Dimethicone Cross- Polymer, Silica, Trigenhenin, Cetyl Peg/PPG-10/1 Dimethicone, Glycerin, Polymethylsilsesquioxane, Disteardimonium Hectorite, Silica Dimethyl Slylate, Zinc Oxide, Phenoxyethanol, Tropolone, Aroma (Flavor), Sodium Dehydroacetate, Methicone, Ascorbyl Palmitate, Disodium EDTA, Retinyl Palmitate, Tocopheryl Acetate, Dimethicone/Vinyl Dimethicone CrossPolymer, Steareth-20, Alumina, Caprylyl Glycol, Camellia Sinensis Leaf Extract, Palmitoyl Tetra-Peptide-7, Butylene Glycol, Caprylic/Capric Triglyceride, Salicornia Herb-Acae Extract, Diaminopropionoyl Tripeptide-33, Titanium Dioxide (CI77891), Iron Oxide (CI77492), Iron Oxide (CI77491), Iron Oxide (CI77499)

Uses

  • Helps prevent sunburn
  • Higher SPF gives more sun protection

Warnings
For external use only.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if rash or irritation develops and lasts.

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

Directions

  • Apply generously 30 minutes before sun exposure and as needed
  • Children under 6 months of age: ask a doctor
  • Reapply as needed or after towel drying, swimming or sweating

Other Information

You may report a serious adverse reaction to Report Reaction, LLC PO Box 22, Plainsboro, NJ 08536-0222

FL. OZ 2500

Manuf. Date

Batch

Fusion Brands America Inc.

444 Madison Avenue

7th Floor, New York, NY 10022

QSC-75018 Paris-France

Manufactured in Italy

Packaged in USA

PRIMER RESULTS TINTED MOISTURIZER SPF15 CARAMEL

PRIMER RESULTS TINTED MOISTURIZER SPF15 CARAMEL 
octinoxate, octisalate, titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51327-210
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE6 mL  in 100 mL
OCTISALATE (OCTISALATE) OCTISALATE4 mL  in 100 mL
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE2.7 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
DIMETHICONE 
WATER 
ISODODECANE 
SILICON DIOXIDE 
TRIBEHENIN 
GLYCERIN 
ZINC OXIDE 
PHENOXYETHANOL 
TROPOLONE 
SODIUM DEHYDROACETATE 
ASCORBYL PALMITATE 
EDETATE DISODIUM 
VITAMIN A PALMITATE 
ALPHA-TOCOPHEROL ACETATE 
STEARETH-20 
ALUMINUM OXIDE 
CAPRYLYL GLYCOL 
GREEN TEA LEAF 
BUTYLENE GLYCOL 
TRICAPRIN 
TITANIUM DIOXIDE 
Packaging
#Item CodePackage Description
1NDC:51327-210-0073934 mL in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35211/08/2010
Labeler - Fusion Brands (785073078)
Establishment
NameAddressID/FEIOperations
Gotha Cosmetics378071679manufacture

Revised: 11/2010
 
Fusion Brands

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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