HISSYFIT  BODY DOUBLE MOISTURIZER- avobenzone, oxybenzone, octinoxate, octocrylene and titanium dioxide lotion 
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®
body double
nourishing body moisturizer + 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

  • luxurious body lotion with SPF 30+ to provide moisturization to entire body and high sunburn protection
  • 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 body 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, lanolin, cetearyl alcohol, stearic acid, dimethicone, glycerin, glyceryl stearate, sodium PCA, centipeda cunninghamii (australian daisy) extract, aloe barbadensis leaf juice, citrus grandis (grapefruit) peel oil, citrus aurantium dulcis (orange) peel Oil, phenoxyethanol, caprylyl glycol, emulsifying wax, tocopheryl acetate, fragrance, titanium dioxide, xanthan gum, carbomer, triethanolamine, disodium EDTA

Distributed by
Valeant Pharmaceuticals N.A.
Aliso Viejo, CA 92656 USA
C9992001BT
Rev. 5/10

PRINCIPAL DISPLAY PANEL - 125mL Tube Carton

body double
nourishing body moisturizer + SPF

hissyfit®

SPF 30+
broad spectrum
UVA/UVB
protection

vanilla almond orange grapefruit

125mL / 4.2 fl.oz.

PRINCIPAL DISPLAY PANEL - 125mL Tube Carton
HISSYFIT   BODY DOUBLE MOISTURIZER
avobenzone, oxybenzone, octinoxate, octocrylene, and titanium dioxide lotion
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0187-1720
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Avobenzone (Avobenzone) Avobenzone2 g  in 125 mL
Oxybenzone (Oxybenzone) Oxybenzone5 g  in 125 mL
Octinoxate (Octinoxate) Octinoxate7.5 g  in 125 mL
Octocrylene (Octocrylene) Octocrylene3 g  in 125 mL
Titanium Dioxide (Titanium) Titanium Dioxide0.2 g  in 125 mL
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-1720-01125 mL 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: b000e785-6bd3-4bca-945f-567afe8c5aff
Set id: a1afacd7-922e-4dd7-9330-8c06db69e7e7
Version: 1
Effective Time: 20100707
 
Valeant Pharmaceuticals International