NDC | 67938-1130-1, 67938-1130-2 |
Set ID | b8bcb692-3a6c-4c57-8fd2-1298011bd245 |
Category | HUMAN OTC DRUG LABEL |
Packager | Elizabeth Arden, Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
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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
- WARNINGS
- OTC - ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- DOSAGE & ADMINISTRATION
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - PURPOSE
- OTC - WHEN USING
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
EIGHT HOUR CREAM TARGETED SUN DEFENSE SPF 50
homosalate stickProduct 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)