INTERVENE DAILY MOISTURE SPF 15 OIL FREE- octinoxate and oxybenzone lotion

Intervene Daily Moisture SPF 15 Oil Free by

Drug Labeling and Warnings

Intervene Daily Moisture SPF 15 Oil Free by is a Otc medication manufactured, distributed, or labeled by Elizabeth Arden, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

This lightweight, oil free moisturizing lotion, powered by alpha and beta hydroxy compounds, refines, clarifies and retexturizes skin for a naturally radiant appearance. SPF 15 UVA/UVB sunscreens and antioxidant vitamins C and E protect skin from sun and pollution while an advanced hydrating system helps keep skin soft, smooth, and healthy looking all day long. Sensitive skin tested. Oil Free. Clinically, dermatologist and allergy tested.

INDICATIONS AND USAGE

To Use: Apply daily to face and throat before sun exposure.

WARNINGS

Warning: 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 to prevent sunburnm not skin cancer or early skin aging.  For external us only.

OTC - ACTIVE INGREDIENT

Active Ingredients: Octinoxate 6.0% w/w, Oxybenzone 3.0% w/w.

INACTIVE INGREDIENT

Other 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, BENZYL SALICYLATE, BUTYLPHENYL METHYLPROPIONAL, CITRONELLOL, HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE, LIMONENE, LINALOOL, DMDM HYDANTOIN, METHYLPARABEN, PHENOXYETHANOL, PROPYLPARABEN.

DOSAGE & ADMINISTRATION

Apply liberally 15 minutes before sun exposure.  Reapply: at least every 2 hours.

OTC - KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTC - PURPOSE

SPF 15 UVA/UVB sunscreens protect skin from sun.

OTC - WHEN USING

Avoid contact with eyes.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

INTERVENE DAILY MOISTURE SPF 15 OIL FREE 
octinoxate and oxybenzone lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67938-0577
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	3600 mg  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1800 mg  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)
GLYCERIN (UNII: PDC6A3C0OX)
ISOSTEARIC ACID (UNII: X33R8U0062)
STEARETH-21 (UNII: 53J3F32P58)
ALUMINUM STARCH OCTENYLSUCCINATE (UNII: I9PJ0O6294)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
PEG-100 STEARATE (UNII: YD01N1999R)
CETYL ALCOHOL (UNII: 936JST6JCN)
PANTHENOL (UNII: WV9CM0O67Z)
SODIUM LACTATE (UNII: TU7HW0W0QT)
STEARETH-2 (UNII: V56DFE46J5)
C12-20 ACID PEG-8 ESTER (UNII: 9M7A3K4339)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
TRILAURETH-4 PHOSPHATE (UNII: M96W2OLL2V)
HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) (UNII: 997385V0VV)
DMDM HYDANTOIN (UNII: BYR0546TOW)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
TOCOPHEROL (UNII: R0ZB2556P8)
RETINYL LINOLEATE (UNII: 61911N8D6W)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)
BENZYL SALICYLATE (UNII: WAO5MNK9TU)
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE (UNII: QUE43B9Z2Q)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67938-0577-1	1 in 1 BOX
1	NDC: 67938-0577-2	50 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	09/24/2013

Labeler - Elizabeth Arden, Inc (849222187)