BLUMINGO ANTI-AGING AM SPF-30 SUNSCREEN- homosalate, octocrylene, octisalate, avobenzone, oxybenzone cream 
BLUMINGO 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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BLUMINGO ANTI-AGING AM SPF-30 SUNSCREEN

ACTIVE INGREDIENTS

HOMOSALATE  15%

OCTOCRYLENE  10%

OCTISALATE  5%

AVOBENZONE  3%

OXYBENZONE 1.5%

PURPOSE

SUNSCREEN

USES

  • HELPS PREVENT SUNBURN

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 A DOCTOR IF RASH OCCURS.

KEEP OUT OF REACH OF CHILDREN

IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT AWAY.

DIRECTIONS

  • FOR SUNSCREEN USE:
  • APPLY GENEROUSLY AND EVENLY 15 MINUTES BEFORE SUN EXPOSURE.
  • REAPPLY AT LEAST EVERY 2 HOURS.
  • 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 10AM - 2PM - WEAR LONG-SLEEVED SHIRTS, PANTS, HATS, AND SUNGLASSES.

OTHER INFORMATION

  • PROTECT THIS PRODUCT IN THIS CONTAINER FROM EXCESSIVE HEAT AND DIRECT SUN.

INACTIVE INGREDIENTS

WATER (AQUA), GLYCERIN, C12-15 ALKYL BENZOATE, PHEXOXYETHANOL, ETHYLHEXYLGLYCERIN, SODIUM HYDROXIDE, CARBOMER, ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, DISODIUM EDTA, RETINOL, METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER, TOCOPHERYL ACETATE, ASCORBIC ACID, PROPYL GALLATE, BHT, XANTHAN GUM, BLUE 1, FRAGRANCE, RED 33.

blumingo_box_AM_nolines

BLUMINGO ANTI-AGING AM SPF-30 SUNSCREEN 
homosalate, octocrylene, octisalate, avobenzone, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71823-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE15 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE3 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE1.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
GLYCERIN (UNII: PDC6A3C0OX)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
CARBOMER 940 (UNII: 4Q93RCW27E)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
RETINOL (UNII: G2SH0XKK91)  
METHYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: EG97988M5Q)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
ASCORBIC ACID (UNII: PQ6CK8PD0R)  
PROPYL GALLATE (UNII: 8D4SNN7V92)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
XANTHAN GUM (UNII: TTV12P4NEE)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71823-101-1130 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/201801/21/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35201/13/201801/21/2020
Labeler - BLUMINGO LLC (094256031)
Establishment
NameAddressID/FEIBusiness Operations
COSMOBEAUTI LABORATORIES & MANUFACTURING, INC.021687376manufacture(71823-101)

Revised: 1/2020
Document Id: 44ed2561-f524-4118-ac97-29fc658b5fc1
Set id: 5e9afea3-03fc-4b58-ae58-aebb317a634f
Version: 3
Effective Time: 20200121
 
BLUMINGO LLC