PREVENTAGE FIRMING DEFENSE CREME NORMAL/ OILY BROAD SPECTRUM SPF 15- avobenzone, octocrylene cream

Preventage Firming Defense Creme Normal/ Oily Broad Spectrum SPF 15 by

Drug Labeling and Warnings

Preventage Firming Defense Creme Normal/ Oily Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by Merle Norman Cosmetics. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients (w/w): Purpose

Avobenzone 1.9% Sunscreen

Octocrylene 9.4% Sunscreen

PURPOSE

Uses

• helps prevent sunburn
• If used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

KEEP OUT OF REACH OF CHILDREN

When using this product, keep out of eyes. Rinse with water to remove.

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs

WARNINGS

Warnings

For external use only

Do not use on damaged or broken skin

DOSAGE & ADMINISTRATION

Directions

• For sunscreen use:
• apply liberally and evenly 15 minutes before sun exposure
• use a water resistant sunscreen if swimming or sweating
• reapply at least every 2 hours
• children under 6 months: Ask a doctor
• Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:
• limit time in the sun, especially from 10 a.m. - 2 p.m.
• wear long-sleeved shirts, pants, hats, and sunglasses

INACTIVE INGREDIENT

Inactive (non-medicinal) ingredients: Aqua/Water/Eau, Butylene Glycol, Cyclopentasiloxane, Cyclohexasiloxane, Hamamelis Virginiana (Witch Hazel) Bark/leaf/twig Extract, Glyceryl Polymethacrylate, Dipalmitoyl hydroxyproline, octyldodecyl Neopentanoate, Phenyl Trimethicone, PPG-20 Methyl Glucose Ether, Hydrolyzed Malt Extract, Propylene Glycol, Myristyl Lactate, Sorbitan Stearate, Stearic Acid, Stearyl Alcohol, Alcohol, Triethanolamine, Phenoxyethanol, Biosaccharide Gum-1, Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate, Bisabolol, Carbomer, Dimethicone, Hydrolyzed Elastin, PEG-100 Stearate, Glycerin, PEG-8, Sorbitol, Caprylyl Glycol, Myristyl Alcohol, Tocopheryl Acetate, Calluna Vulgaris Flower Extract, Collagen Amino Acids, PEG-7M, Polysorbate 60, Ethylhexylglycerin, Phospholipids, Silica, Cucumis Sativus (Cucumber) Fruit Extract, Ginkgo Biloba Leaf Extract, Glycyrrhetinic Acid, Ruscus Aculeatus Root Extract, Hexylene Glycol, Lectithin, Tetrasodium EDTA, Hydrolyzed Rice Protein, Disodium EDTA, Camellia Sinensis Leaf Extract, PVP, Echinacea Angustifolia Extract, Chlorphenesin, Hyaluronic Acid, Polyquaternium-24, Ilex Aquifolium (Holly) Leaf Extract, Sodium Oleanolate, Sodium Ursolate, Ascorbyl Palmitate, Euphrasia Officinalis Extract, Retinyl Palmitate, Palmitoyl Hexapeptide-12.

PRINCIPAL DISPLAY PANEL

Preventage Firming Defense Creme

Normal / Oily

Broad Spectrum SPF 15

Merle Norman

Established in Los Angeles Since 1931

56 g Net Wt. 2 OZ

INGREDIENTS AND APPEARANCE

PREVENTAGE FIRMING DEFENSE CREME NORMAL/ OILY BROAD SPECTRUM SPF 15 
avobenzone, octocrylene cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57627-186
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.9 g  in 100 g
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	9.4 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SORBITOL (UNII: 506T60A25R)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
CALLUNA VULGARIS FLOWERING TOP (UNII: D9PC510CQV)
POLYETHYLENE OXIDE 300000 (UNII: 4QIB4U4CQR)
EDETATE DISODIUM (UNII: 7FLD91C86K)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
ILEX AQUIFOLIUM LEAF (UNII: 9Z32IEA9F7)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
EUPHRASIA STRICTA (UNII: C9642I91WL)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
TROLAMINE (UNII: 9O3K93S3TK)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
POLYSORBATE 60 (UNII: CAL22UVI4M)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
ALCOHOL (UNII: 3K9958V90M)
LEVOMENOL (UNII: 24WE03BX2T)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
PEG-100 STEARATE (UNII: YD01N1999R)
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)
SODIUM URSOLATE (UNII: NV5D25VL1O)
CYCLOMETHICONE 6 (UNII: XHK3U310BA)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
PPG-20 METHYL GLUCOSE ETHER (UNII: 3WV1T97D3K)
MYRISTYL LACTATE (UNII: 1D822OC34X)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
DIMETHICONE (UNII: 92RU3N3Y1O)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
GLYCERIN (UNII: PDC6A3C0OX)
STEARIC ACID (UNII: 4ELV7Z65AP)
HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW) (UNII: ZR28QKN0WT)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
WATER (UNII: 059QF0KO0R)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
GINKGO (UNII: 19FUJ2C58T)
ENOXOLONE (UNII: P540XA09DR)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
RUSCUS ACULEATUS ROOT (UNII: ZW12V95I1Q)
POVIDONE (UNII: FZ989GH94E)
ECHINACEA ANGUSTIFOLIA WHOLE (UNII: VB06AV5US8)
CHLORPHENESIN (UNII: I670DAL4SZ)
HYALURONIC ACID (UNII: S270N0TRQY)
EDETATE SODIUM (UNII: MP1J8420LU)
CUCUMBER (UNII: YY7C30VXJT)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57627-186-01	56 g in 1 CARTON; Type 0: Not a Combination Product	01/17/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	01/17/2022

Labeler - Merle Norman Cosmetics (008479388)

Registrant - Merle Norman Cosmetics (008479388)