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

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

Drug Labeling and Warnings

Preventage Firming Defense Creme Normal/Dry Broad Spectrum SPF 15 by is a Otc medication manufactured, distributed, or labeled by Merle Norman Cosmetics, Inc.. 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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

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
Apply to cleansed and toned skin prior to sun exposure

WARNINGS

Warnings

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.

INACTIVE INGREDIENT

Inactive (non-medicinal) ingredients: Aqua/Water/Eau, Glycerin, Butyloctyl Salicylate, Diethylhexyl Maleate, Jojoba Esters, Cyclopentasiloxane, C10-30 Cholesterol/Lanosterol Esters, Phenyl Trimethicone, Stearic Acid, Stearyl Alcohol, Glyceryl Polymethacrylate, Biosaccharide Gum-1, Sorbitan Stearate, Propylene Glycol, Dimethicone, Dipalmitoyl Hydroxyproline, PEG-100 Stearate, Polysorbate 60, PPG-20 Methyl Glucose Ether, Hydrolyzed Malt Extract, Tocopheryl Acetate, Phenoxyethanol, Bis-Ethylhexyl Hydroxydimethoxy Benzylmalonate, Bisabolol, Cetearyl Methicone, Hydrolyzed Elastin, Hamamelis Virginiana (Witch Hazel) Bark/Leaf/Twig Extract, PEG-8, Alcohol, Triethanolamine, Sorbital, Lecithin, Caprylyl Glycol, Collagen Amino Acids, PEG-7M, Carbomer, Dimethicone/Vinyl Dimethicone Crosspolymer, Ethylhexylglycerin, Phospholipids, Silica, Calluna Vulgaris Flower Extract, Glycyrrhethic Acid, Glycyrrhetinic Acid, Hexylene Glycol, Butylene Glycol, Tetrasodium EDTA, Hydrolyzed Rice Protein, Disodium EDTA, Camellia Sinensis Leaf Extract, PVP, Cucumis Sativus (Cucumber) Fruit Extract, Ginkgo Biloba Leaf Extract, Ruscus Aculeatus Root Extract, Echinacea angustifolia extract, Chlorphenesin, Hyaluronic Acid, Polyquaternium-24, Ilex Aquifolium (Holly) Leaf Extract, Sodium Oleanolate, Sodium Ursolate, Ascorbyl Palmitate, Euphrasia Officinalis Extract, Retinyl Palmitate, Diazolidinyl Urea, Yellow 5 (CI 19140), Imidazolidinyl Urea, Palmitoyl Hexapeptide-12, Methylparaben, Red 4 (CI 14700)

STORAGE AND HANDLING

Other Information

• protect the product from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57627-203
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
SORBITOL (UNII: 506T60A25R)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
BUTYLOCTYL SALICYLATE (UNII: 2EH13UN8D3)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
SODIUM URSOLATE (UNII: NV5D25VL1O)
CHLORPHENESIN (UNII: I670DAL4SZ)
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (HARD PARTICLE) (UNII: H895X08VNQ)
CUCUMBER (UNII: YY7C30VXJT)
TROLAMINE (UNII: 9O3K93S3TK)
GINKGO (UNII: 19FUJ2C58T)
ENOXOLONE (UNII: P540XA09DR)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
AMINO ACIDS (UNII: 0O72R8RF8A)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
POVIDONE (UNII: FZ989GH94E)
HYALURONIC ACID (UNII: S270N0TRQY)
SODIUM OLEANOLATE (UNII: LVB19G8AUT)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
FD&C RED NO. 4 (UNII: X3W0AM1JLX)
WATER (UNII: 059QF0KO0R)
DIETHYLHEXYL MALEATE (UNII: C2F7JHI12L)
C10-30 CHOLESTEROL/LANOSTEROL ESTERS (UNII: 137SL7IL0Y)
BIOSACCHARIDE GUM-1 (UNII: BB4PU4V09H)
POLYSORBATE 60 (UNII: CAL22UVI4M)
HYDROLYZED BOVINE ELASTIN (BASE; 1000 MW) (UNII: ZR28QKN0WT)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R)
STEARIC ACID (UNII: 4ELV7Z65AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
PPG-20 METHYL GLUCOSE ETHER (UNII: 3WV1T97D3K)
ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
LEVOMENOL (UNII: 24WE03BX2T)
CETEARYL METHICONE (15000 MW) (UNII: VY9RTR7MSY)
DIPALMITOYL HYDROXYPROLINE (UNII: E6AHA53N1H)
PEG-100 STEARATE (UNII: YD01N1999R)
CALLUNA VULGARIS FLOWERING TOP (UNII: D9PC510CQV)
EDETATE SODIUM (UNII: MP1J8420LU)
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)
BASIC YELLOW 5 (UNII: 07BP340B4T)
IMIDUREA (UNII: M629807ATL)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
BIS-ETHYLHEXYL HYDROXYDIMETHOXY BENZYLMALONATE (UNII: 7D4Q5YJ8NV)
HAMAMELIS VIRGINIANA TOP (UNII: UDA30A2JJY)
POLYETHYLENE OXIDE 300000 (UNII: 4QIB4U4CQR)
EUPHRASIA STRICTA (UNII: C9642I91WL)
PALMITOYL HEXAPEPTIDE-12 (UNII: HO4ZT5S86C)
METHYLPARABEN (UNII: A2I8C7HI9T)
ILEX AQUIFOLIUM LEAF (UNII: 9Z32IEA9F7)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
ALCOHOL (UNII: 3K9958V90M)
RUSCUS ACULEATUS ROOT (UNII: ZW12V95I1Q)
ECHINACEA ANGUSTIFOLIA (UNII: VB06AV5US8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57627-203-01	56 g in 1 JAR; Type 0: Not a Combination Product	11/15/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part352	11/15/2021

Labeler - Merle Norman Cosmetics, Inc. (008479388)

Establishment
Name	Address	ID/FEI	Business Operations
Merle Norman Cosmetics, Inc.		008479388	manufacture(57627-203)