EIGHT HOUR CREAM TARGETED SUN DEFENSE SPF 50- homosalate stick

Eight Hour Cream Targeted Sun Defense SPF 50 by

Drug Labeling and Warnings

Eight Hour Cream Targeted Sun Defense SPF 50 by is a Otc medication manufactured, distributed, or labeled by Elizabeth Arden, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

PRINCIPAL DISPLAY PANEL

 

 

 

INGREDIENTS AND APPEARANCE

EIGHT HOUR CREAM TARGETED SUN DEFENSE SPF 50 
homosalate stick

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-1130
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	0.51 g  in 6.8 g
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	0.51 g  in 6.8 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	0.34 g  in 6.8 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	0.27 g  in 6.8 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	0.14 g  in 6.8 g

Inactive Ingredients
Ingredient Name	Strength
OCTYLDODECYL MYRISTATE (UNII: S013N99GR8)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-1130-1	1 in 1 BOX
1	NDC: 67938-1130-2	6.8 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	07/12/2010

Labeler - Elizabeth Arden, Inc (849222187)