24K SKIN TONE MOISTURIZER SPF 30- octinoxate, homosalate, octisilate, oxybenzone and avobenzone cream 
Vivo Per-lei, Inc.

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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24K Skin Tone Moisturizer SPF 30

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 a 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

OROGOLD®
cosmetics

24K SKIN TONE SPF 30
BROAD SPECTRUM
TON DE PEAU 24K FPS 30

50g / 1.76oz

image-01

Label

24K SKIN TONE MOISTURIZER SPF 30 
octinoxate, homosalate, octisilate, oxybenzone and avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69201-952
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)  
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)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69201-952-841 in 1 CARTON07/29/2019
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 finalpart35207/29/2019
Labeler - Vivo Per-lei, Inc. (003061508)

Revised: 7/2022
Document Id: 65cbc280-cab2-482b-b657-e889b789a9bc
Set id: d0ee20e0-0092-4add-905a-713e585fe0f6
Version: 3
Effective Time: 20220725
 
Vivo Per-lei, Inc.