OROGOLD® cosmetics 24K BIO-BRIGHTENING DARK CIRCLE EYE SOLUTION

24K Bio-Brightening Dark Circle Eye SPF 30 by

Drug Labeling and Warnings

24K Bio-Brightening Dark Circle Eye SPF 30 by is a Otc medication manufactured, distributed, or labeled by Vivo Per-lei, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

24K BIO-BRIGHTENING DARK CIRCLE EYE SPF 30- zinc oxide and titanium oxide solution 
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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OROGOLD® cosmetics 24K BIO-BRIGHTENING DARK CIRCLE EYE SOLUTION

Active ingredient

Zinc Oxide 10.0%

Titanium Oxide 5.00%

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 use 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, Polysorbate 60, Glycerin, Cetearyl Alcohol, Cyclopentasiloxane, Sodium Polystyrene Sulfonate, Glyceryl Stearate, PEG-100 Stearate, Coconut Alkanes, Polyhydroxystearic, Stearic Acid, Alumina, Coco-Capylate/Caprate, Olea Europaea Fruit Oil, Cocos Nucifera Oil, Butyruspermum Parkii Butter, Cucumis Sativa Fruit Extract, Camellia Sinensis Leaf Extract, Chamomilla Recutita Flower Extract, Aloe Barbadensis Leaf Extract, Arnica Montana Flower Extract, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Xanthan Gum, Triethanolamine, Punica Granatum Extract, Dimethicone, Ethylhexylglycerin, Benzyl Alcohol, Gold, Disodium EDTA.

Package/Label Principal Display Panel

OROGOLD®
cosmetics

24K BIO-BRIGHTENING
DARK CIRCLE
EYE SOLUTION

SPF 30
BROAD SPECTRUM

30ml / 1 fl.oz

HYPO
ALLERGENIC

DERMATOLOGIST
TESTED

Paraben-free

Always do a skin patch test 24 hours before using this product.
Caution: For External Use Only
Made in U.S.A

OROGOLD®
cosmetics
20255 Corisco St. Chatsworth, CA 91311
www.orogoldcosmetics.com

Customer Service
USA: +1-877-554-1777
International: +1-786-587-1965
Cservice@orogoldcosmetics.com

Carton Label

Carton Label

24K BIO-BRIGHTENING DARK CIRCLE EYE SPF 30 
zinc oxide and titanium oxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69201-966
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE10 g  in 100 mL
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
POLYSORBATE 60 (UNII: CAL22UVI4M)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
SODIUM POLYSTYRENE SULFONATE (UNII: 1699G8679Z)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
COCONUT ALKANES (UNII: 1E5KJY107T)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
COCO-CAPRYLATE/CAPRATE (UNII: 8D9H4QU99H)  
OLIVE OIL (UNII: 6UYK2W1W1E)  
PUNICA GRANATUM ROOT BARK (UNII: CLV24I3T1D)  
COCONUT OIL (UNII: Q9L0O73W7L)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
CHAMOMILE (UNII: FGL3685T2X)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
ARNICA MONTANA FLOWER (UNII: OZ0E5Y15PZ)  
GOLD (UNII: 79Y1949PYO)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
XANTHAN GUM (UNII: TTV12P4NEE)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
TROLAMINE (UNII: 9O3K93S3TK)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 69201-966-881 in 1 CARTON10/03/201412/31/2019
130 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35210/03/201412/31/2019
Labeler - Vivo Per-lei, Inc. (003061508)

Revised: 7/2019
 
Vivo Per-lei, Inc.