SKINCARE LDEL RETINOL DAY BROAD SPECTRUM SPF 20- avobenzone, homosalate, oxybenzone, and octinoxate cream

Skincare LdeL Retinol by

Drug Labeling and Warnings

Skincare LdeL Retinol by is a Otc medication manufactured, distributed, or labeled by Beauty Solutions, Ltd. , PhytogenX, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients:

Avobenzone 2%

Homosalate 3%

Octinoxate 7.5%

Oxybenzone 5%

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

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.

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.

Stop use and ask doctor if rash occurs.

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions:

• Apply liberally 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.
• Apply to all skin exposed to the sun.

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 am to 2 pm.
• Wear long-sleeve shirts, pants, hat and sunglasses.

Other information:

• Protect the product in this container from excessive heat and direct sunlight.
• You may report a serious adverse reaction from using this product to Beauty Solutions, Ltd. 411 Fifth Avenue, New York, NY 10016.

Inactive ingredients:

Water, Glycerin, Cetearyl Alcohol, Petrolatum, Argania Spinosa Kernel Oil, Glyceryl Stearate, Tocopheryl Acetate, Phenoxyethanol, Retinyl Palmitate, PEG-40 Stearate, PEG-8 Stearate, Stearic Acid, Fragrance (Parfum), Amyl Cinnamal, Benzyl Salicylate, Citronellol, Coumarin, Eugenol, Alpha-isomethyl Ionone, Geraniol, Hexyl Cinnamal, Butylphenyl Methylpropional, Linalool, Methylparaben, Carbomer, BHT, Silk Amino Acids, Sodium Hydroxide, Propylparaben, Ascorbyl Palmitate, Chitosan PCA, Xanthan Gum, Ethylparaben, Bisabolol, Disodium EDTA.

Principal Display Panel - 63g Jar Carton

Skincare LdeL Cosmetics®
RETINOL

VITAMIN ENRICHED

Day Cream
Broad Spectrum SPF 20

Daily Moisturizing Cream
to Nourish and Protect

Net Wt. 63 g 2.25 Oz.

INGREDIENTS AND APPEARANCE

SKINCARE LDEL RETINOL   DAY BROAD SPECTRUM SPF 20
avobenzone, homosalate, oxybenzone, and octinoxate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51117-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Avobenzone (UNII: G63QQF2NOX) (Avobenzone - UNII:G63QQF2NOX)	Avobenzone	20 mg  in 1 g
Homosalate (UNII: V06SV4M95S) (Homosalate - UNII:V06SV4M95S)	Homosalate	30 mg  in 1 g
Oxybenzone (UNII: 95OOS7VE0Y) (Oxybenzone - UNII:95OOS7VE0Y)	Oxybenzone	50 mg  in 1 g
Octinoxate (UNII: 4Y5P7MUD51) (Octinoxate - UNII:4Y5P7MUD51)	Octinoxate	75 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Glycerin (UNII: PDC6A3C0OX)
Argan Oil (UNII: 4V59G5UW9X)
.Alpha.-Tocopherol Acetate (UNII: 9E8X80D2L0)
Levomenol (UNII: 24WE03BX2T)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Petrolatum (UNII: 4T6H12BN9U)
Glyceryl Monostearate (UNII: 230OU9XXE4)
Phenoxyethanol (UNII: HIE492ZZ3T)
Methylparaben (UNII: A2I8C7HI9T)
Propylparaben (UNII: Z8IX2SC1OH)
Ethylparaben (UNII: 14255EXE39)
Vitamin A Palmitate (UNII: 1D1K0N0VVC)
Peg-40 Stearate (UNII: ECU18C66Q7)
Peg-8 Stearate (UNII: 2P9L47VI5E)
Stearic Acid (UNII: 4ELV7Z65AP)
Sodium Hydroxide (UNII: 55X04QC32I)
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
Amino Acids, Silk (UNII: V0L00EX1IA)
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)
Xanthan Gum (UNII: TTV12P4NEE)
Edetate Disodium (UNII: 7FLD91C86K)
Ascorbyl Palmitate (UNII: QN83US2B0N)
.Alpha.-Amylcinnamaldehyde (UNII: WC51CA3418)
Benzyl Salicylate (UNII: WAO5MNK9TU)
.Beta.-Citronellol, (R)- (UNII: P01OUT964K)
Coumarin (UNII: A4VZ22K1WT)
Eugenol (UNII: 3T8H1794QW)
Isomethyl-.Alpha.-Ionone (UNII: 9XP4LC555B)
Geraniol (UNII: L837108USY)
.Alpha.-Hexylcinnamaldehyde (UNII: 7X6O37OK2I)
Butylphenyl Methylpropional (UNII: T7540GJV69)
Linalool, (+/-)- (UNII: D81QY6I88E)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51117-001-01	1 in 1 CARTON	09/05/2012
1		63 g in 1 JAR; Type 0: Not a Combination Product
2	NDC: 51117-001-02	1 in 1 CARTON	09/05/2012
2		50 g in 1 JAR; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part352	09/05/2012

Labeler - Beauty Solutions, Ltd. (184041981)

Establishment
Name	Address	ID/FEI	Business Operations
PhytogenX, Inc.		624386772	MANUFACTURE(51117-001)