BLUMINGO ANTI-AGING AM SPF-30 SUNSCREEN

BLUMINGO ANTI-AGING AM SPF-30 SUNSCREEN by

Drug Labeling and Warnings

BLUMINGO ANTI-AGING AM SPF-30 SUNSCREEN by is a Otc medication manufactured, distributed, or labeled by BLUMINGO LLC, COSMOBEAUTI LABORATORIES & MANUFACTURING, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71823-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	15 g  in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	10 g  in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g  in 100 mL
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g  in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	1.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71823-101-11	30 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/13/2018	01/21/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	01/13/2018	01/21/2020

Labeler - BLUMINGO LLC (094256031)

Establishment
Name	Address	ID/FEI	Business Operations
COSMOBEAUTI LABORATORIES & MANUFACTURING, INC.		021687376	manufacture(71823-101)

Revised: 1/2020

Document Id: 44ed2561-f524-4118-ac97-29fc658b5fc1

34390-5

Set id: 5e9afea3-03fc-4b58-ae58-aebb317a634f

Version: 3

Effective Time: 20200121

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