FRESH SKIN EFFORTLESS BEAUTY BALM BROAD SPECTRUM SPF 35

Manufacturer: AERIN LAUDER BEAUTY DIST. | ELGC K.K. | ESTEE LAUDER COMPANY, THE | ESTEE LAUDER COSMETICS, LTD | ESTEE LAUDER COSMETICS, LTD. | ESTEE LAUDER N.V. | LEN-RON MANUFACTURING DIVISION OF ARAMIS INC | NORTHTEC INC | NORTHTEC LLC | PADC 1 | WHITMAN LABORATORIES, LTD. | Aveda Corporation | Pennsylvania Logistics Center (PALC)
Effective date: 2014-12-19
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:41:21

Label at a glance#

ProductFRESH SKIN EFFORTLESS BEAUTY BALM BROAD SPECTRUM SPF 35

Active ingredientOCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, ZINC OXIDE

Label structure8 sections

Dosage and administration

For sunscreen use: apply liberally 15 minutes before sun exposure reapply at least every two hours use a 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...

Storage and handling

protect the product in this container from excessive heat and direct sun

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients	Purpose
Octinoxate 7.50%	Sunscreen
Octisalate 4.00%	Sunscreen
Oxybenzone 2.50%	Sunscreen
Titanium Dioxide 1.10%	Sunscreen
Zinc Oxide 3.30%	Sunscreen

Use

INDICATIONS & USAGE SECTION

helps prevent sunburn

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

For sunscreen use:

apply liberally 15 minutes before sun exposure
reapply at least every two hours
use a 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
children under 6 months of age: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

water\aqua\eau • dimethicone • butylene glycol • phenyl trimethicone • pentylene glycol • glyceryl stearate • behenyl alcohol • trioctyldodecyl citrate • polymethylsilsesquioxane • octyldodecyl stearoyl stearate • peg-40 stearate • polyglyceryl-10 pentastearate • tocopheryl acetate • sodium hyaluronate • lecithin • squalane • triticum vulgare (wheat) germ extract • hordeum vulgare (barley) extract\extrait d'orge • cucumis sativus (cucumber) fruit extract • laminaria saccharina extract • pyrus malus (apple) fruit extract • scutellaria baicalensis root extract • glycerin • caffeine • cholesterol • oryzanol • trehalose • octyldodecyl neopentanoate • polyglyceryl-6 polyricinoleate • acetyl hexapeptide-8 • sodium pca • sucrose • urea • polyquaternium-51 • sodium stearoyl lactylate • ammonium acryloyldimethyltaurate/vp copolymer • polysorbate 20 • sorbitan laurate • propylene glycol laurate • glycyrrhetinic acid • linoleic acid • stearic acid • xanthan gum • silica • isopropyl titanium triisostearate • alumina • propylene glycol stearate • disodium edta • sodium dehydroacetate • chlorphenesin • phenoxyethanol • [+/- mica • iron oxides (ci 77491) • iron oxides (ci 77492) • iron oxides (ci 77499) • titanium dioxide (ci 77891)] <iln41064>

Other information

STORAGE AND HANDLING SECTION

protect the product in this container from excessive heat and direct sun

PRINCIPAL DISPLAY PANEL - 50 ml Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AERIN

FRESH SKIN
EFFORTLESS BEAUTY BALM
BROAD SPECTRUM SPF 35

1.7 FL. OZ. LIQ/50ml e

Principal Display Panel - 50 ml Tube Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7dea7767-9f52-b60a-5435-33cb9cc28bae	Product name	4	20250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4	Product name	7	20250116
0ca83774-3f79-b837-5d6f-c210102f3bc8	Product name	6	20250114
41b814f3-0166-1c53-c9ef-a0794c7daf9d	Product name	3	20221110
a590be26-846c-8659-a5a1-fb25907965dc	Product name	2	20221110
2dc76302-91c0-4c35-ad78-99adfb049c4b	Product name	1	20200603
e6065d4b-5ae1-476f-a40e-f2851cbb5d2b	Product name	2	20180221
f212291f-05fe-9603-fc7e-bd73e38ce1e6	Product name	2	20161129
182f9ab4-4ab5-c449-200f-87ce2ce8e550	Product name	2	20151105
332e86c3-7875-ca6e-f934-2206d2b31996	Product name	1	20140508
56625fcc-aa34-9d30-d0e9-1c1beb37ea21	Product name	1	20140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092	Product name	1	20140508
96c2be53-8e44-452d-56a2-d255b2f1af2d	Product name	1	20140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44	Product name	1	20140508
d223c173-c39b-d764-47d4-d671d3088815	Product name	1	20140508
e01133ad-4dcd-c7f3-454b-2ff569ee160a	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
43072-001-01	2020-01-31	C162847	48780-1	9d75b9d1-08cd-f424-e053-dadaa90a57ce	FRESH SKIN EFFORTLESS BEAUTY BALM BROAD SPECTRUM SPF 35

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
43072-001-01	FRESH SKIN EFFORTLESS BEAUTY BALM BROAD SPECTRUM SPF 35	1 in 1 CARTON	CREAM	1		1
43072-001-01	FRESH SKIN EFFORTLESS BEAUTY BALM BROAD SPECTRUM SPF 35	50 mL in 1 TUBE	CREAM	50		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
43072-001	FRESH SKIN EFFORTLESS BEAUTY BALM BROAD SPECTRUM SPF 35 (OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, AND ZINC OXIDE) CREAM [AERIN LAUDER BEAUTY DIST.]	1	Legacy NDC, 2 package rows	20150114_0db9148d-e1bd-46b9-925f-1952da4e1b0b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	1
OCTISALATE	ACTIVE INGREDIENT	4X49Y0596W	1
OXYBENZONE	ACTIVE INGREDIENT	95OOS7VE0Y	1
TITANIUM DIOXIDE	ACTIVE INGREDIENT	15FIX9V2JP	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	1
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	1
OCTISALATE	ACTIVE MOIETY	4X49Y0596W	1
OXYBENZONE	ACTIVE MOIETY	95OOS7VE0Y	1
TITANIUM DIOXIDE	ACTIVE MOIETY	15FIX9V2JP	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	1
.alpha.-tocopherol acetate	INACTIVE INGREDIENT	9E8X80D2L0	1
acetyl hexapeptide-8	INACTIVE INGREDIENT	L4EL31FWIL	1
aluminum oxide	INACTIVE INGREDIENT	LMI26O6933	1
ammonium acryloyldimethyltaurate/vp copolymer	INACTIVE INGREDIENT	W59H9296ZG	1
apple	INACTIVE INGREDIENT	B423VGH5S9	1
barley	INACTIVE INGREDIENT	5PWM7YLI7R	1
butylene glycol	INACTIVE INGREDIENT	3XUS85K0RA	1
caffeine	INACTIVE INGREDIENT	3G6A5W338E	1
chlorphenesin	INACTIVE INGREDIENT	I670DAL4SZ	1
cholesterol	INACTIVE INGREDIENT	97C5T2UQ7J	1
cucumber	INACTIVE INGREDIENT	YY7C30VXJT	1
dimethicone	INACTIVE INGREDIENT	92RU3N3Y1O	1
docosanol	INACTIVE INGREDIENT	9G1OE216XY	1
edetate disodium	INACTIVE INGREDIENT	7FLD91C86K	1
enoxolone	INACTIVE INGREDIENT	P540XA09DR	1
ferric oxide red	INACTIVE INGREDIENT	1K09F3G675	1
ferric oxide yellow	INACTIVE INGREDIENT	EX438O2MRT	1
ferrosoferric oxide	INACTIVE INGREDIENT	XM0M87F357	1
gamma oryzanol	INACTIVE INGREDIENT	SST9XCL51M	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	1
hyaluronate sodium	INACTIVE INGREDIENT	YSE9PPT4TH	1
isopropyl titanium triisostearate	INACTIVE INGREDIENT	949E3KBJ1I	1
linoleic acid	INACTIVE INGREDIENT	9KJL21T0QJ	1
mica	INACTIVE INGREDIENT	V8A1AW0880	1
octyldodecyl neopentanoate	INACTIVE INGREDIENT	X8725R883T	1
octyldodecyl stearoyl stearate	INACTIVE INGREDIENT	3D47Q6D93C	1
peg-40 stearate	INACTIVE INGREDIENT	ECU18C66Q7	1
pentylene glycol	INACTIVE INGREDIENT	50C1307PZG	1
phenoxyethanol	INACTIVE INGREDIENT	HIE492ZZ3T	1
phenyl trimethicone	INACTIVE INGREDIENT	DR0K5NOJ4R	1
polysorbate 20	INACTIVE INGREDIENT	7T1F30V5YH	1
propylene glycol monolaurate	INACTIVE INGREDIENT	668Z5835Z3	1
propylene glycol stearate	INACTIVE INGREDIENT	MZM1I680W0	1
saccharina latissima	INACTIVE INGREDIENT	68CMP2MB55	1
scutellaria baicalensis root	INACTIVE INGREDIENT	7J95K7ID2S	1
silicon dioxide	INACTIVE INGREDIENT	ETJ7Z6XBU4	1
sodium dehydroacetate	INACTIVE INGREDIENT	8W46YN971G	1
sodium pyrrolidone carboxylate	INACTIVE INGREDIENT	469OTG57A2	1
sodium stearoyl lactylate	INACTIVE INGREDIENT	IN99IT31LN	1
sorbitan monolaurate	INACTIVE INGREDIENT	6W9PS8B71J	1
squalane	INACTIVE INGREDIENT	GW89575KF9	1
stearic acid	INACTIVE INGREDIENT	4ELV7Z65AP	1
sucrose	INACTIVE INGREDIENT	C151H8M554	1
trehalose	INACTIVE INGREDIENT	B8WCK70T7I	1
trioctyldodecyl citrate	INACTIVE INGREDIENT	35X8CT063R	1
urea	INACTIVE INGREDIENT	8W8T17847W	1
water	INACTIVE INGREDIENT	059QF0KO0R	1
wheat germ	INACTIVE INGREDIENT	YR3G369F5A	1
xanthan gum	INACTIVE INGREDIENT	TTV12P4NEE	1

Products#

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

DailyMed product names page 1 of 2 · 57 matching rows.

FRESH SKIN EFFORTLESS BEAUTY BALM BROAD SPECTRUM SPF 35
OCTINOXATE, OCTISALATE, OXYBENZONE, TITANIUM DIOXIDE, and ZINC OXIDE
OCTINOXATE
OCTISALATE
OXYBENZONE
TITANIUM DIOXIDE
ZINC OXIDE
water
dimethicone
butylene glycol
phenyl trimethicone
pentylene glycol
glyceryl monostearate
docosanol
trioctyldodecyl citrate
octyldodecyl stearoyl stearate
peg-40 stearate
.alpha.-tocopherol acetate
hyaluronate sodium
squalane
wheat germ
barley
cucumber
saccharina latissima
apple
scutellaria baicalensis root
glycerin
caffeine
cholesterol
gamma oryzanol
trehalose
octyldodecyl neopentanoate
acetyl hexapeptide-8
sodium pyrrolidone carboxylate
sucrose
urea
sodium stearoyl lactylate
ammonium acryloyldimethyltaurate/vp copolymer
polysorbate 20
sorbitan monolaurate

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
43072-001	43072-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 2 · 55 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
OCTINOXATE	4Y5P7MUD51	ACTIB
OCTISALATE	4X49Y0596W	ACTIB
OXYBENZONE	95OOS7VE0Y	ACTIB
TITANIUM DIOXIDE	15FIX9V2JP	ACTIB
ZINC OXIDE	SOI2LOH54Z	ACTIB
water	059QF0KO0R	IACT
dimethicone	92RU3N3Y1O	IACT
butylene glycol	3XUS85K0RA	IACT
phenyl trimethicone	DR0K5NOJ4R	IACT
pentylene glycol	50C1307PZG	IACT
glyceryl monostearate	230OU9XXE4	IACT
docosanol	9G1OE216XY	IACT
trioctyldodecyl citrate	35X8CT063R	IACT
octyldodecyl stearoyl stearate	3D47Q6D93C	IACT
peg-40 stearate	ECU18C66Q7	IACT
.alpha.-tocopherol acetate	9E8X80D2L0	IACT
hyaluronate sodium	YSE9PPT4TH	IACT
squalane	GW89575KF9	IACT
wheat germ	YR3G369F5A	IACT
barley	5PWM7YLI7R	IACT
cucumber	YY7C30VXJT	IACT
saccharina latissima	68CMP2MB55	IACT
apple	B423VGH5S9	IACT
scutellaria baicalensis root	7J95K7ID2S	IACT
glycerin	PDC6A3C0OX	IACT
caffeine	3G6A5W338E	IACT
cholesterol	97C5T2UQ7J	IACT
gamma oryzanol	SST9XCL51M	IACT
trehalose	B8WCK70T7I	IACT
octyldodecyl neopentanoate	X8725R883T	IACT
acetyl hexapeptide-8	L4EL31FWIL	IACT
sodium pyrrolidone carboxylate	469OTG57A2	IACT
sucrose	C151H8M554	IACT
urea	8W8T17847W	IACT
sodium stearoyl lactylate	IN99IT31LN	IACT
ammonium acryloyldimethyltaurate/vp copolymer	W59H9296ZG	IACT
polysorbate 20	7T1F30V5YH	IACT
sorbitan monolaurate	6W9PS8B71J	IACT
propylene glycol monolaurate	668Z5835Z3	IACT
enoxolone	P540XA09DR	IACT

Source Document#

Source XML

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 · 471 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
squalane	SQUALANE	GW89575KF9	CREAM / TOPICAL	6 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	GEL / TOPICAL		58 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	IMPLANT / SUBCUTANEOUS	1.04 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET / SUBLINGUAL	9 mg		Exact identifier — unii candidate 26 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	LOZENGE / ORAL		1264 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		23 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ferric oxide yellow	FERRIC OXIDE YELLOW	EX438O2MRT	POWDER / RESPIRATORY (INHALATION)	0.04 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	POWDER, FOR SUSPENSION / ORAL	1203 mg/5ml		Exact identifier — unii candidate 26 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	TABLET / SUBLINGUAL	109 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, SOLUTION / INTRAMUSCULAR	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
ferric oxide yellow	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET / SUBLINGUAL	1 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	POWDER, FOR SUSPENSION / ORAL		285 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION/ DROPS / ORAL		22 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	SUSPENSION, EXTENDED RELEASE / ORAL	186.8 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
ferric oxide yellow	FERRIC OXIDE YELLOW	EX438O2MRT	TABLET, ORALLY DISINTEGRATING / ORAL		2 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, EMULSION / INTRAVENOUS		59 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	SOAP / TOPICAL	6 %w/w		Exact identifier — unii candidate 26 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	POWDER / ORAL		27768 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SUSPENSION / ORAL		80 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	POWDER / ORAL	275 mg		Exact identifier — unii candidate 29 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION / INFILTRATION		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	AEROSOL, FOAM / RECTAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SOLUTION, CONCENTRATE / ORAL	200 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE / ORAL	13.75 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	POWDER, FOR SOLUTION / ORAL		38666 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	FILM, SOLUBLE / ORAL		1 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	SYRUP / ORAL		46400 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
stearic acid	STEARIC ACID	4ELV7Z65AP	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 26 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	INJECTION / SUBCUTANEOUS		450 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SOLUTION / INTRAVENOUS	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
ferrosoferric oxide	FERROSOFERRIC OXIDE	XM0M87F357	TABLET / ORAL		2 mg	Exact identifier — unii candidate 10 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SHAMPOO, SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 77 equally ranked IID candidates
sorbitan monolaurate	SORBITAN MONOLAURATE	6W9PS8B71J	AEROSOL / TOPICAL	4.74 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	TROCHE / ORAL		948 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	PASTE / DENTAL	34 %w/w		Exact identifier — unii candidate 49 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
urea	UREA	8W8T17847W	CREAM / VAGINAL	0.64 %w/w		Exact identifier — unii candidate 7 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS	9.4 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 28 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
xanthan gum	XANTHAN GUM	TTV12P4NEE	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.6 %w/w		Exact identifier — unii candidate 29 equally ranked IID candidates
butylene glycol	BUTYLENE GLYCOL	3XUS85K0RA	SYSTEM / TRANSDERMAL	8.12 mg		Exact identifier — unii candidate 2 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	SOLUTION / ORAL		336 mg	Exact identifier — unii candidate 49 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	EMULSION / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
ferric oxide yellow	FERRIC OXIDE YELLOW	EX438O2MRT	CAPSULE, DELAYED RELEASE / ORAL		3 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	INJECTION, SOLUTION / INTRAVENOUS	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
polysorbate 20	POLYSORBATE 20	7T1F30V5YH	SPRAY, METERED / NASAL		40 mg	Exact identifier — unii candidate 28 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
edetate disodium	EDETATE DISODIUM	7FLD91C86K	ELIXIR / ORAL	1.3 mg/5ml		Exact identifier — unii candidate 77 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	EMULSION / OPHTHALMIC		3 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
xanthan gum	XANTHAN GUM	TTV12P4NEE	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		6 mg	Exact identifier — unii candidate 29 equally ranked IID candidates
sucrose	SUCROSE	C151H8M554	PASTILLE / ORAL	426 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
silicon dioxide	SILICON DIOXIDE	ETJ7Z6XBU4	TABLET, FILM COATED / ORAL		166 mg	Exact identifier — unii candidate 49 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
18412891-9023-4e11-930b-75efe3bc9340			0db9148d-e1bd-46b9-925f-1952da4e1b0b	2014-12-19	Warnings	Exact identifier spl id: 18412891-9023-4e11-930b-75efe3bc9340 spl set id: 0db9148d-e1bd-46b9-925f-1952da4e1b0b

Reported adverse events (FAERS/openFDA)#

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