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

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.

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Drug Facts

Active ingredients:

Avobenzone 2%

Homosalate 3%

Octinoxate 7.5%

Oxybenzone 5%

Purpose

Sunscreen

Sunscreen

Sunscreen

Sunscreen

Uses:

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:

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:

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.

Principal Display Panel - 63g Jar Carton
SKINCARE LDEL RETINOL   DAY BROAD SPECTRUM SPF 20
avobenzone, homosalate, oxybenzone, and octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51117-001
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
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 NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:51117-001-011 in 1 CARTON09/05/2012
163 g in 1 JAR; Type 0: Not a Combination Product
2NDC:51117-001-021 in 1 CARTON09/05/2012
250 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart35209/05/2012
Labeler - Beauty Solutions, Ltd. (184041981)
Establishment
NameAddressID/FEIBusiness Operations
PhytogenX, Inc.624386772MANUFACTURE(51117-001)

Revised: 11/2019
Document Id: a79c3a19-0c78-433d-8a40-f105c956dbd8
Set id: 76e2ed34-c643-402b-9c9d-04eac789d3c2
Version: 2
Effective Time: 20191111
 
Beauty Solutions, Ltd.