Eight Hour Cream Targeted Sun Defense SPF 50

Dosage form: stick
Ingredients: HOMOSALATE 0.51g in 6.8g, OCTINOXATE 0.51g in 6.8g, OCTOCRYLENE 0.34g in 6.8g, OXYBENZONE 0.27g in 6.8g, AVOBENZONE 0.14g in 6.8g
Labeler: Elizabeth Arden, Inc
NDC Code: 67938-1130

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.

BC1130

DESCRIPTION

Target over-exposed areas such as lips, nose, earlobes, even scars to shield from the burning and aging effects of UVA and UVB rays. Eight Hour Cream hydrating benefits sooth and smooth for up to 8 hours.

Oil-free. Water-resistant. PABA-free. Non-acnegenic. Perspiration-resistant. Suitable for all skin types. Ophthalmologist, clinically and dermatologist tested.

Uses: Helps prevent sunburn. Higher SPF gives more sunburn protection. Retains SPF after 40 minutes of swimming or perspiring.

Sun Alert: Limiting sun exposure, wearing protective clothing and using sunscreens may reduce the risk of skin cancer and other harmful effects of the sun.

INDICATIONS AND USAGE

Directions: Apply liberally and evenly to targeted areas 30 minutes before sun exposure and as needed. Reapply after 40 minutes of swimming or perspiring, and after towel drying. Otherwise, reapply at least every 2 hours. Children under 6 months of age: ask a doctor.

WARNINGS

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 controll center right away.

OTC - ACTIVE INGREDIENT

Active Ingredients: Homosalate 7.5% w/w, Octinoxate 7.5% w/w, Octocrylene 5.0% w/w, Oxybenzone 4.0% w/w, Avobenzone 2.0% w/w.

INACTIVE INGREDIENT

Other Ingredients: Octyldodecyl Myristate, Polyethylene, Phenyl Trimethicone, Tocopheryl Acetate, Caprylyl Glycol, Parfum/Fragrance, Citral, Citronellol, Geraniol, Limonene, Linalool, Phenoxyethanol.

DOSAGE & ADMINISTRATION

Apply evenly and liberally to targeted areas.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTC - PURPOSE

Helps prevent sunburn. Higher SPF gives more sun protection.

OTC - WHEN USING

Keep out of eyes.

 

 

 

EIGHT HOUR CREAM TARGETED SUN DEFENSE SPF 50 
homosalate stick
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-1130
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (HOMOSALATE) HOMOSALATE0.51 g  in 6.8 g
OCTINOXATE (OCTINOXATE) OCTINOXATE0.51 g  in 6.8 g
OCTOCRYLENE (OCTOCRYLENE) OCTOCRYLENE0.34 g  in 6.8 g
OXYBENZONE (OXYBENZONE) OXYBENZONE0.27 g  in 6.8 g
AVOBENZONE (AVOBENZONE) AVOBENZONE0.14 g  in 6.8 g
Inactive Ingredients
Ingredient NameStrength
OCTYLDODECYL MYRISTATE 
PHENYL TRIMETHICONE 
PHENOXYETHANOL 
CAPRYLYL GLYCOL 
Packaging
#Item CodePackage Description
1NDC:67938-1130-11 TUBE (1 TUBE) in 1 BOX
1NDC:67938-1130-26.8 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35207/12/2010
Labeler - Elizabeth Arden, Inc (849222187)

Revised: 01/2011
 
Elizabeth Arden, 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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