OROGOLD® cosmetics 24K BIO-BRIGHTENING SKIN TONE MOISTURIZER SPF 30

24K Bio-Brightening Skin Tone Moisturizer SPF 30 by

Drug Labeling and Warnings

24K Bio-Brightening Skin Tone Moisturizer 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 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.

----------

OROGOLD® cosmetics 24K BIO-BRIGHTENING SKIN TONE MOISTURIZER SPF 30

Active ingredient

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 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, 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 BIO-BRIGHTENING
SKIN TONE MOISTURIZER

SPF 30
BROAD SPECTRUM

50g / 1.76oz

US FDA (Food and Drug Administration) Registered Facility.

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 SKIN TONE MOISTURIZER SPF 30 
octinoxate, homosalate, octisilate, oxybenzone and avobenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 69201-852
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 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: 69201-852-831 in 1 CARTON10/03/201412/31/2019
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 finalpart35210/03/201412/31/2019
Labeler - Vivo Per-lei, Inc. (003061508)

Revised: 7/2019
Document Id: b51af89a-ac42-4a1d-9b6d-c7f68dc0ad02
Set id: efe14f38-3320-41ee-9538-6019e6d2938a
Version: 3
Effective Time: 20190729
 
Vivo Per-lei, Inc.