Topcare Daily Facial

Dosage form: cream
Ingredients: AVOBENZONE 3mL in 100mL, OCTOCRYLENE 10mL in 100mL
Labeler: Topco Associates LLC
NDC Code: 36800-326

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.

TopCare®  Daily Facial Moisturizer

Active ingredient

Avobenzone 3.0%

Octocrylene 10.0%

Purpose

Sunscreen

Uses
  • helps prevent sunburn
  • If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

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 a Poison Control Center right away.

Directions
  • Apply liberally 15 minutes before sun exposure.
  • Children under 6 months of age: ask a doctor
  • 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 a.m. - 2 p.m.
    • wear long-sleeved shirts, pants, hats and sunglasses

Other Information
  • protect the product in this container from excessive heat and direct sun

Inactive Ingredients

water, disopropyl adipate, cyclopentasiloxane, glycerin, glyceryl stearate, PEG-100 stearate, titanium dioxide, alumina, simethicone, polymethyl methacrylate, phenoxyethanol, benzyl alcohol, triethanolamine, acrylates/C10-30 alkylacrylate crosspolymer, tocopheryl acetate (vitamin E), carbomer, disodium EDTA

Package/Label Principal Display Panel - Carton Label

TopCare®

Daily Facial Moisturizer Broad Spectrum SPF15 Sunscreen

non-greasy and lightweight

protects from UVA and UVB rays

non-comedogenic (won't clog pores)

fragrance-free and paba-free

dermatologist tested

*Compare to Cetaphil® Daily Facial Moisturizer SPF 15 Ingredients

4 FL OZ (118 mL)

DISTRIBUTED BY TOPCO
ASSOCIATES LLC
7711 GROSS POINT ROAD,
SKOKIE, IL 60077 © TOPC ELL512
QUESTIONS? 1-888-423-0139
topcare@topco.com

Carton Label

TOPCARE DAILY FACIAL 
avobenzone, octocrylene cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-326
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (AVOBENZONE) AVOBENZONE3 mL  in 100 mL
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE10 mL  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DIISOPROPYL ADIPATE 
CYCLOMETHICONE 5 
GLYCERIN 
GLYCERYL MONOSTEARATE 
PEG-100 STEARATE 
TITANIUM DIOXIDE 
ALUMINUM OXIDE 
DIMETHICONE 
POLY(METHYL ACRYLATE-CO-METHYL METHACRYLATE-CO-METHACRYLIC ACID 7:3:1; 280000 MW) 
PHENOXYETHANOL 
BENZYL ALCOHOL 
TROLAMINE 
CARBOMER INTERPOLYMER TYPE A (55000 MPA.S) 
.ALPHA.-TOCOPHEROL ACETATE 
CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) 
EDETATE DISODIUM 
Packaging
#Item CodePackage Description
1NDC:36800-326-021 BOTTLE in 1 CARTON
1118 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35206/01/2012
Labeler - Topco Associates LLC (006935977)

Revised: 06/2012
 
Topco Associates 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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