Intervene Daily Moisture SPF 15 Oil Free

Dosage form: lotion
Ingredients: OCTINOXATE 3600mg in 50mL, OXYBENZONE 1800mg in 50mL
Labeler: Elizabeth Arden, Inc
NDC Code: 67938-0577

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.

BB0577

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.

INTERVENE DAILY MOISTURE SPF 15 OIL FREE 
octinoxate and oxybenzone lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67938-0577
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (OCTINOXATE) OCTINOXATE3600 mg  in 50 mL
OXYBENZONE (OXYBENZONE) OXYBENZONE1800 mg  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
DIMETHICONE 
ISONONYL ISONONANOATE 
GLYCERIN 
ISOSTEARIC ACID 
STEARETH-21 
ALUMINUM STARCH OCTENYLSUCCINATE 
OCTYLDODECYL NEOPENTANOATE 
GLYCERYL STEARATE SE 
PEG-100 STEARATE 
CETYL ALCOHOL 
PANTHENOL 
SODIUM LACTATE 
STEARETH-2 
C12-20 ACID PEG-8 ESTER 
TETRAHEXYLDECYL ASCORBATE 
TRILAURETH-4 PHOSPHATE 
HYDROLYZED GLYCOSAMINOGLYCANS (BOVINE; 50000 MW) 
DMDM HYDANTOIN 
METHYLPARABEN 
PROPYLENE GLYCOL 
PROPYLPARABEN 
TOCOPHEROL 
RETINYL LINOLEATE 
PHENOXYETHANOL 
BUTYLPHENYL METHYLPROPIONAL 
BENZYL SALICYLATE 
HYDROXYISOHEXYL 3-CYCLOHEXENE CARBOXALDEHYDE 
Packaging
#Item CodePackage Description
1NDC:67938-0577-11 BOTTLE in 1 BOX
1NDC:67938-0577-250 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35209/24/2013
Labeler - Elizabeth Arden, Inc (849222187)

Revised: 12/2013
 
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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