OTC Medication Information: Flawless Finish Bare Perfection Makeup SPF 8 Honey

FLAWLESS FINISH BARE PERFECTION MAKEUP SPF 8 HONEY- octinoxate lotion
Elizabeth Arden, Inc

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.

DESCRIPTION

For normal skin. Medium coverage. Natural finish. This oil free liquid makeup gives skin a firmer look and reflects light to soften fine lines. SPF 8 provides sun protection. Clinically, dermatologist and allergy tested.

INDICATIONS AND USAGE

To Use: Smooth on to face before sun exposure.

WARNINGS

Warning: For external use only. Keep out of eyes.Stop use and see a doctor is rash or irritation develops and lasts. Keep out of reach of children.

OTC — ACTIVE INGREDIENT

Active Ingredient: Octinoxate 4.0% w/w.

INACTIVE INGREDIENT

Other Ingredients: Water/Aqua/Eau, Isostearyl Palmitate, C12-15 Alkyl Benzoate, Butylene Glycol, Dimethicone, Oleic Acid, Glycerin, C12-20 Acid PEG-8 Ester, Polysorbate 40, Triethanolamine, Magnesium Aluminum Silicate, Dimethicone Copolyol, Phenyl Trimethicone, Sodium Hyaluronate, Retinyl Linoleate, Tocopherol, Glyceryl Stearate SE, Sucrose Laurate, Trehalose, Lecithin, Phospholipids, Tridecyl Salicylate, Decyl Glucoside, PEG-40 Stearate, Sorbitan Palmitate, Sorbitan Stearate, Behenyl Alcohol, Carbomer, Xanthan Gum, Disodium EDTA, Kaolin, Silica, Cyclopentasiloxane, Dimethiconol, Parfum/Fragrance, Butylphenyl Methylpropional, Hydroxycitronellal, Hydroxyisohexyl 3-Cyclohexene Carboxaldehyde, Limonene, Butylparaben, Ethylparaben, Isobutylparaben, Methylparaben, Phenoxyethanol, Propylparaben, Iron Oxides (CI77491, CI 77492, CI 77499), Titanium Dioxide (CI 77891).

DOSAGE & ADMINISTRATION

Smooth on to face.

OTC — KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OTC — PURPOSE

SPF 8 provides sun protection.

OTC — WHEN USING

Keep out of eyes.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Flawless Finish Bare Perfection Makeup Carton
(click image for full-size original)

FLAWLESS FINISH BARE PERFECTION MAKEUP SPF 8 HONEY
octinoxate lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:67938-0827
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
OCTINOXATE (OCTINOXATE) OCTINOXATE 1.1988 mL in 30 mL
Inactive Ingredients
Ingredient Name Strength
WATER
TITANIUM DIOXIDE
BUTYLENE GLYCOL
ALKYL (C12-15) BENZOATE
DIMETHICONE
OLEIC ACID
GLYCERIN
POLYSORBATE 40
MAGNESIUM ALUMINUM SILICATE
TROLAMINE
PHENYL TRIMETHICONE
KAOLIN
XANTHAN GUM
PHENOXYETHANOL
SUCROSE LAURATE
DICAPRYLYL CARBONATE
GLYCERYL MONOSTEARATE
METHYLPARABEN
DOCOSANOL
PROPYLPARABEN
SORBITAN MONOPALMITATE
Product Characteristics
Color BROWN (Honey) Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:67938-0827-1 1 BOTTLE, PUMP (1 BOTTLE) in 1 BOX contains a BOTTLE, PUMP (67938-0827-2)
1 NDC:67938-0827-2 30 mL in 1 BOTTLE, PUMP This package is contained within the BOX (67938-0827-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part352 05/06/2011
Labeler — Elizabeth Arden, Inc (849222187)

Revised: 05/2011 Elizabeth Arden, Inc

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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