NDC | 67938-1000-1, 67938-1000-2 |
Set ID | d1560161-3114-4ff3-8cc1-2a1d99d95fd3 |
Category | HUMAN OTC DRUG LABEL |
Packager | Elizabeth Arden, Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- DESCRIPTION
- INDICATIONS AND USAGE
-
WARNINGS
Warnings:
Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown only to prevent sunburn, not skin cancer or early skin aging.
For external use only
Do not use on damaged or broken skin
When using this product keep out of eyes. Rinse with water to remove.
Stop use and ask a doctor if rash occurs
- OTC - ACTIVE INGREDIENT
-
INACTIVE INGREDIENT
Inactive Ingredients: Water/Aqua/Eau, Dimethicone, Isononyl Isononanoate, Glycerin, Tridecyl Salicylate, Steareth-21, Isostearic Acid, Octyldodecyl Neopentanoate, Aluminum Starch Octenylsuccinate, Salvia Officinalis (Sage) Leaf Extract, Hydrolyzed Glycosaminoglycans, Sodium Hyaluronate, Sodium Lactate, Retinyl Linoleate, Tetrahexyldecyl Ascorbate, Tocopherol, Glyceryl Stearate, Propylene Glycol, Panthenol, C12-20 Acid PEG-8 Ester, Cetyl Alcohol, PEG-100 Stearate, Trilaureth-4 Phosphate, Steareth-2 Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Ethylene/VA Copolymer, Sclerotium Gum, Triethanolamine, BHT, Disodium EDTA, Parfum/Fragrance, Benxyl Salicylate, Butylphenyl Methylpropional, Citronellol, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Linalool, DMDM Hydantoin, Methylparaben, Phenoxyethanol, Propylparaben.
- DOSAGE & ADMINISTRATION
- OTC - KEEP OUT OF REACH OF CHILDREN
- OTC - PURPOSE
- OTC - WHEN USING
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
VISIBLE DIFFERENCE SKIN BALANCING SUNSCREEN SPF 15
octinoxate and oxybenzone lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67938-1000 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE 60 mg in 50 mL OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 30 mg in 50 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) DIMETHICONE (UNII: 92RU3N3Y1O) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) GLYCERIN (UNII: PDC6A3C0OX) TRIDECYL SALICYLATE (UNII: AZQ08K38Z1) STEARETH-21 (UNII: 53J3F32P58) ISOSTEARIC ACID (UNII: X33R8U0062) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294) SAGE (UNII: 065C5D077J) HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV) HYALURONATE SODIUM (UNII: YSE9PPT4TH) SODIUM LACTATE (UNII: TU7HW0W0QT) RETINYL LINOLEATE (UNII: 61911N8D6W) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) TOCOPHEROL (UNII: R0ZB2556P8) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PANTHENOL (UNII: WV9CM0O67Z) PEG-100 STEARATE (UNII: YD01N1999R) TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V) STEARETH-2 (UNII: V56DFE46J5) EDETATE DISODIUM (UNII: 7FLD91C86K) BENZYL SALICYLATE (UNII: WAO5MNK9TU) BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69) .BETA.-CITRONELLOL, (R)- (UNII: P01OUT964K) HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q) DMDM HYDANTOIN (UNII: BYR0546TOW) METHYLPARABEN (UNII: A2I8C7HI9T) PHENOXYETHANOL (UNII: HIE492ZZ3T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67938-1000-1 1 in 1 CARTON 1 NDC:67938-1000-2 50 mL in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/16/2011 Labeler - Elizabeth Arden, Inc (849222187)