Abella Skin Care Inc. ColorShade SPF 35 Tinted Sunscreen Lotion - Medium

Manufacturer: Prime Enterprises Inc.
Effective date: 2020-01-17
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-05-31 23:02:58

Label at a glance#

ProductAbella ColorShade SPF 35 Medium

Active ingredientZINC OXIDE, OCTINOXATE

Label structure9 sections

Indications and uses

helps prevent sunburn if used as directed with other sun protection measures (see Directions ), decreases the risk of skin cancer and early skin aging caused by the sun

Dosage and administration

apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying 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 spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, especially fr...

Contacts and useful links#

PhoneLabel contact1-877-622-3552

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 3%

Zinc Oxide 3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

SPL UNCLASSIFIED SECTION

helps prevent sunburn
if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use on damaged or broken skin

OTC - WHEN USING SECTION

When using this product keep out of eyes.

Rinse with water to remove.

OTC - STOP USE SECTION

Stop use and ask a doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

apply liberally 15 minutes before sun exposure
reapply:
after 80 minutes of swimming or sweating
immediately after towel drying
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 spectrum SPF 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
children under 6 months: Ask a doctor

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Juice, Bentonite, Camellia Sinensis (Green Tea) Leaf Extract, Caramel, Cetyl Dimethicone, Cetyl PEG/PPG-10/1 Dimethicone, Cholecalciferol, Cyclomethicone, Disodium EDTA, DMDM Hydantoin, Hexyl Laurate, Hydrogenated Castor Oil, Iron Oxides, Isocetyl Stearate, Melanin, Octyl Stearate, Polyethylene, Polyglyceryl-4 Isostearate, Propylene Glycol, Prunus Amygdalus Dulcis (Sweet Almond) Oil, Silica, Sodium Chloride, Titanium Dioxide, Tocopheryl Acetate, Water (Aqua)

Other Information

OTHER SAFETY INFORMATION

protect this product from excessive heat and direct sun

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-877-622-3552

Abella Skin care Inc. ColorShade SPF 35 Medium

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display Image

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
58443-0195-3	2023-01-30	C162847	48780-1	f386c64a-4095-0266-e053-dadaa90a7c1a	Abella Skin Care Inc. ColorShade SPF 35 Tinted Sunscreen Lotion - Medium

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
58443-0195-3	AbellaColorShade SPF 35 Medium	60 mL in 1 BOTTLE	LOTION	60		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
58443-0195	ABELLA COLORSHADE SPF 35 MEDIUM (OCTINOXATE AND ZINC OXIDE) LOTION [PRIME ENTERPRISES INC.]	3	Legacy NDC, 1 package rows	20200118_2185064e-163b-5a59-e054-00144ff8d46c.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	1
ALMOND OIL	INACTIVE INGREDIENT	66YXD4DKO9	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	1
ALPHA-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	1
BENTONITE	INACTIVE INGREDIENT	A3N5ZCN45C	1
CARAMEL	INACTIVE INGREDIENT	T9D99G2B1R	1
CETYL DIMETHICONE 45	INACTIVE INGREDIENT	IK315POC44	1
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)	INACTIVE INGREDIENT	V2W71V8T0X	1
CHOLECALCIFEROL	INACTIVE INGREDIENT	1C6V77QF41	1
CYCLOMETHICONE	INACTIVE INGREDIENT	NMQ347994Z	1
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
FERRIC OXIDE RED	INACTIVE INGREDIENT	1K09F3G675	1
GREEN TEA LEAF	INACTIVE INGREDIENT	W2ZU1RY8B0	1
HEXYL LAURATE	INACTIVE INGREDIENT	4CG9F9W01Q	1
HIGH DENSITY POLYETHYLENE	INACTIVE INGREDIENT	UG00KM4WR7	1
HYDROGENATED CASTOR OIL	INACTIVE INGREDIENT	ZF94AP8MEY	1
ISOCETYL STEARATE	INACTIVE INGREDIENT	3RJ7186O9W	1
MELANIN SYNTHETIC (TYROSINE, PEROXIDE)	INACTIVE INGREDIENT	O0CV1RMR44	1
OCTYL STEARATE	INACTIVE INGREDIENT	772Y4UFC8B	1
POLYGLYCERYL-4 ISOSTEARATE	INACTIVE INGREDIENT	820DPX33S7	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	1
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	1
TRIETHOXYCAPRYLYLSILANE	INACTIVE INGREDIENT	LDC331P08E	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 30 matching rows.

Abella ColorShade SPF 35 Medium
Octinoxate and Zinc Oxide
SODIUM CHLORIDE
ALMOND OIL
SILICON DIOXIDE
GREEN TEA LEAF
BENTONITE
TITANIUM DIOXIDE
CARAMEL
CETYL DIMETHICONE 45
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)
CHOLECALCIFEROL
HIGH DENSITY POLYETHYLENE
CYCLOMETHICONE
PROPYLENE GLYCOL
DMDM HYDANTOIN
HEXYL LAURATE
HYDROGENATED CASTOR OIL
FERRIC OXIDE RED
ISOCETYL STEARATE
MELANIN SYNTHETIC (TYROSINE, PEROXIDE)
WATER
ALOE VERA LEAF
.ALPHA.-TOCOPHEROL ACETATE
EDETATE DISODIUM
OCTYL STEARATE
POLYGLYCERYL-4 ISOSTEARATE
TRIETHOXYCAPRYLYLSILANE
ZINC OXIDE
OCTINOXATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
58443-0195	58443-0195-3

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
SODIUM CHLORIDE	451W47IQ8X	IACT
ALMOND OIL	66YXD4DKO9	IACT
SILICON DIOXIDE	ETJ7Z6XBU4	IACT
GREEN TEA LEAF	W2ZU1RY8B0	IACT
BENTONITE	A3N5ZCN45C	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
CARAMEL	T9D99G2B1R	IACT
CETYL DIMETHICONE 45	IK315POC44	IACT
CETYL PEG/PPG-10/1 DIMETHICONE (HLB 2)	V2W71V8T0X	IACT
CHOLECALCIFEROL	1C6V77QF41	IACT
HIGH DENSITY POLYETHYLENE	UG00KM4WR7	IACT
CYCLOMETHICONE	NMQ347994Z	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
DMDM HYDANTOIN	BYR0546TOW	IACT
HEXYL LAURATE	4CG9F9W01Q	IACT
HYDROGENATED CASTOR OIL	ZF94AP8MEY	IACT
FERRIC OXIDE RED	1K09F3G675	IACT
ISOCETYL STEARATE	3RJ7186O9W	IACT
MELANIN SYNTHETIC (TYROSINE, PEROXIDE)	O0CV1RMR44	IACT
WATER	059QF0KO0R	IACT
ALOE VERA LEAF	ZY81Z83H0X	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
OCTYL STEARATE	772Y4UFC8B	IACT
POLYGLYCERYL-4 ISOSTEARATE	820DPX33S7	IACT
TRIETHOXYCAPRYLYLSILANE	LDC331P08E	IACT
ZINC OXIDE	SOI2LOH54Z	ACTIB
OCTINOXATE	4Y5P7MUD51	ACTIB

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 462 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	ELIXIR / ORAL	1.3 mg/5ml		Exact identifier — unii candidate 77 equally ranked IID candidates
CARAMEL	CARAMEL	T9D99G2B1R	LIQUID / ORAL	5.3 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS	0.4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACAUDAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVENOUS		28773 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / SOFT TISSUE		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	SOAP / TOPICAL	1 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, EXTENDED RELEASE / ORAL		450 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TRANSDERMAL		500 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRATHECAL	1.35 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
HYDROGENATED CASTOR OIL	HYDROGENATED CASTOR OIL	ZF94AP8MEY	TABLET, DELAYED RELEASE / ORAL		1337 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAVENOUS	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, CHEWABLE / ORAL		2 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION/ DROPS / AURICULAR (OTIC)		18 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / SUBCUTANEOUS		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / RESPIRATORY (INHALATION)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	CAPSULE, DELAYED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / ORAL		27120 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, COATED / ORAL		49 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	DROPS / ORAL	200 mg/1ml		Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / TOPICAL		126 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / AURICULAR (OTIC)	0.1 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRADERMAL	7 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUPPOSITORY / RECTAL		140 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / PARENTERAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / INTRAMUSCULAR	9 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
SILICON DIOXIDE	SILICON DIOXIDE	ETJ7Z6XBU4	GRANULE, DELAYED RELEASE / ORAL	3.2 mg		Exact identifier — unii candidate 49 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAVITREAL		6 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / ORAL		148 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
CYCLOMETHICONE	CYCLOMETHICONE	NMQ347994Z	LOTION / TOPICAL		3510 mg	Exact identifier — unii candidate 5 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAMUSCULAR		17 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAMUSCULAR		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAVENOUS		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / OPHTHALMIC	1 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / DENTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, FOAM / VAGINAL	6.4 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / EPIDURAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
CARAMEL	CARAMEL	T9D99G2B1R	CAPSULE / ORAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
FERRIC OXIDE RED	FERRIC OXIDE RED	1K09F3G675	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL	0.15 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / IONTOPHORESIS	0.1 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	AEROSOL, METERED / RECTAL	NA		Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, EXTENDED RELEASE / ORAL		10 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TRANSDERMAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
HIGH DENSITY POLYETHYLENE	HIGH DENSITY POLYETHYLENE	UG00KM4WR7	PASTE / DENTAL		60 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / TOPICAL		4522 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM / BUCCAL	1.48 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
BENTONITE	BENTONITE	A3N5ZCN45C	SHAMPOO, SUSPENSION / TOPICAL	3.25 %w/v		Exact identifier — unii candidate 11 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii candidate 81 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
9c587234-feff-9481-e053-2a95a90a6b2a			2185064e-163b-5a59-e054-00144ff8d46c	2020-01-17	Warnings	Exact identifier spl id: 9c587234-feff-9481-e053-2a95a90a6b2a spl set id: 2185064e-163b-5a59-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.