NOELLA 24K AGED DEFENSE SPF 30 BROAD SPECTRUM- octinoxate, homosalate, octisilate, oxybenzone and avobenzone cream 
Florida Private Labeling LLC

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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Noella 24K Aged Defense SPF 30 Broad Spectrum

Active Ingredients

Octinoxate    7.40%
Homosalate  6.20%
Octisalate     5.00%
Oxybenzone 3.10%
Avobenzone 1.50%

Purpose

Sunscreen

Uses

Helps prevent sunburn.

Warnings

For external use only. Do not use on damaged or broken skin.

Keep out of eyes. If contact occurs, rinse with water. If rash or irritation develops, discontinue use and consult your physician.

Stop using this product

and ask doctor if rash or redness develops and lasts.

Keep out of reach of children.

If accidental ingestion, call the Poison Control Center right away.

Directions

After cleansing, apply liberally and evenly 15 minutes before sun exposure. Smooth over face and neck and chest daily for optimal results.
Reapply at least every two (2) hours.
Use water resistant sunscreen if swimming or sweating.

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

For children under 6 months of age: Ask doctor.

Other Information

Protect the product in this container from excessive heat and direct sun. Store at room temperature.

Inactive Ingredients

Aqua, C12-15 Alkyl Benzoate, Glycerin, Glyceryl Stearate, Stearic Acid, PEG-100 Stearate, Phenoxyethanol, Ethylhexylglycerin, Polysorbate 60, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Carbomer, Triethanolamine, Fragrance, Tocopherol, Retinyl Palmitate, Aloe Barbadensis Leaf Extract, Camellia Sinensis Extract, Sodium PCA, Gold, Disodium EDTA.

Package/Label Principal Display Panel – Carton Label

NOELLA

24K AGE DEFENSE SPF 30
BROAD SPECTRUM

PROTECTION ANTI-ÂGE
SPF30 24k

50g / 1.76oz


NOELLA

www.noellacosmetics.com
Customer Service
Cservice@noellacosmetics.com
404 Duval St,
Key West, FL 33040

image-01
NOELLA 24K AGED DEFENSE SPF 30 BROAD SPECTRUM 
octinoxate, homosalate, octisilate, oxybenzone and avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73191-588
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.4 g  in 100 g
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE6.2 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5.0 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3.1 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
GLYCERIN (UNII: PDC6A3C0OX)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
PEG-100 STEARATE (UNII: YD01N1999R)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
TROLAMINE (UNII: 9O3K93S3TK)  
TOCOPHEROL (UNII: R0ZB2556P8)  
VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
GOLD (UNII: 79Y1949PYO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:73191-588-701 in 1 CARTON07/27/2021
150 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/27/2021
Labeler - Florida Private Labeling LLC (081081732)

Revised: 7/2022
Document Id: b0190322-7578-4c23-a68c-f6fe196379fa
Set id: 401f2df0-6265-4d89-ae97-82bb119c74e8
Version: 2
Effective Time: 20220722
 
Florida Private Labeling LLC