HISSYFIT  HANDY WORK- avobenzone, oxybenzone, octinoxate, octocrylene and titanium dioxide cream 
Valeant Pharmaceuticals International

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.

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hissyfit®
handy work
soothing hand cream + spf

Drug Facts

Active ingredientsPurpose
Avobenzone 2.0%Sunscreen
Oxybenzone 5.0%Sunscreen
Octinoxate 7.5%Sunscreen
Octocrylene 3.0%Sunscreen
Titanium Dioxide 0.2%Sunscreen

Uses

  • soothing hand cream with SPF 30 to provide protection and moisturization to hands
  • helps prevent sunburn
  • higher SPF gives more sunburn 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 daily as a hydrating moisturizer. Re-apply 20 mins before sun exposure and as needed
  • children under 6 months of age: ask a doctor
  • to ensure that required protection is maintained, re-apply at regular intervals; especially after vigorous exercise or swimming.

Other information

  • Sun Alert: Limiting sun exposure, wearing protective clothing, and using sunscreens may reduce the risks of skin aging, skin cancer, and other harmful effects of the sun. For topical dermatological use only. Store below 30°C (86° F).

Inactive ingredients

Aqua, isopropyl palmitate, glyceryl stearate, cetearyl alcohol, ceteareth-20, lanolin, sodium PCA, glycerin, dimethicone, stearic acid, glycol distearate, cetearyl alcohol, triethanolamine, aloe barbadensis leaf extract, citrus aurantium dulcis (orange) peel oil, mentha piperita (peppermint) oil, tocopheryl acetate, phenoxyethanol, caprylyl glycol, titanium dioxide, carbomer, disodium EDTA, xanthan gum

Distributed by
Valeant Pharmaceuticals N.A.
Aliso Viejo, CA 92656 USA
C9991901BT
Rev. 5/10

PRINCIPAL DISPLAY PANEL - 50g Tube Carton

handy work
soothing hand cream + spf

hissyfit®

SPF 30
broad spectrum
UVA/UVB
protection

orange mint

50g / net wt. 1.8 oz.

PRINCIPAL DISPLAY PANEL - 50g Tube Carton
HISSYFIT   HANDY WORK
avobenzone, oxybenzone, octinoxate, octocrylene, and titanium dioxide cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0187-1719
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone2 g  in 100 g
Oxybenzone (Oxybenzone) Oxybenzone5 g  in 100 g
Octinoxate (Octinoxate) Octinoxate7.5 g  in 100 g
Octocrylene (Octocrylene) Octocrylene3 g  in 100 g
Titanium Dioxide (Titanium) Titanium Dioxide0.2 g  in 100 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-1719-0150 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35206/30/2010
Labeler - Valeant Pharmaceuticals International (042230623)
Establishment
NameAddressID/FEIBusiness Operations
Laboratoire Dr Renaud Inc202501565MANUFACTURE

Revised: 7/2010
Document Id: 99dfc507-01df-4877-b9d3-4e1e5a6bd2d0
Set id: cc3d9aba-81d6-429e-98b4-4ebe7c063945
Version: 1
Effective Time: 20100706
 
Valeant Pharmaceuticals International