AVOBENZONE, OCTINOXATE

Manufacturer: Gurwitch Products, L.L.C. | Atlantis Laboratories, Inc. | Beauty Manufacturing Solutions Corp.
Effective date: 2015-07-13
Label type: HUMAN OTC DRUG LABEL
Version: 2
Source: legacy-cache
Hydrated at: 2026-08-02 01:31:05

Label at a glance#

ProductLaura Mercier Flawless Skin Mega Moisture Creme Broad Spectrum SPF 15 Sunscreen for Normal/Dry Skin

Active ingredientAVOBENZONE, OCTINOXATE

Label structure8 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

For sunscreen use: apply liberally 15 minutes before sun exposure use a water resistant sunscreen if swimming or sweating 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 t...

Contacts and useful links#

PhoneLabel contact1-888-637-2437

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 2.0%

Octinoxate 7.5%

Uses

INDICATIONS & USAGE 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.

Do not use

OTC - DO NOT USE SECTION

on damaged or broken skin.

When using this product

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

Stop use and ask a doctor if

OTC - STOP USE SECTION

rash occurs.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If 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
use a water resistant sunscreen if swimming or sweating
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 10 a.m. - 2 p.m.
wear long-sleeved shirts, pants, hats, and sunglasses
Children under 6 months of age: Ask a doctor

Other information

SPL UNCLASSIFIED SECTION

Protect the product in this container from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, cyclopentasiloxane, dimethicone, polyglyceryl-4 isostearate, cetyl PEG/PPG-10/1 dimethicone, hexyl laurate, Emu oil, glycerin, sorbitol, cetearyl alcohol, peg-40 castor oil, tocopheryl acetate, potassium cetyl phosphate, petrolatum, polysorbate 60, urea, sodium hyaluronate, allantoin, sodium ascorbate, phenoxyethanol, methylparaben, tetrasodium EDTA, carbomer, isopropylparaben, isobutylparaben, butylparaben, sodium dehydroacetate, aminomethyl propanol, linalool, propylparaben, acrylates/c10-30 alkyl acrylate crosspolymer.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-888-637-2437, M - F 9am - 5 pm CST.

Product Labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

JarBottomCarton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
65342-0945-0	2020-01-31	C162847	48780-1	9d75b9d0-1a98-f424-e053-dadaa90a57ce	Laura Mercier Flawless Skin Mega Moisture Creme Broad Spectrum SPF 15 Sunscreen for Normal/Dry Skin

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
65342-0945	LAURA MERCIER FLAWLESS SKIN MEGA MOISTURE CREME BROAD SPECTRUM SPF 15 SUNSCREEN FOR NORMAL/DRY SKIN (AVOBENZONE, OCTINOXATE) CREAM [GURWITCH PRODUCTS, L.L.C.]	2	Legacy NDC	20150724_fc4806e4-234a-49fc-b205-c25f43db041d.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
AVOBENZONE	ACTIVE INGREDIENT	G63QQF2NOX	2
OCTINOXATE	ACTIVE INGREDIENT	4Y5P7MUD51	2
AVOBENZONE	ACTIVE MOIETY	G63QQF2NOX	2
OCTINOXATE	ACTIVE MOIETY	4Y5P7MUD51	2
.ALPHA.-TOCOPHEROL ACETATE	INACTIVE INGREDIENT	9E8X80D2L0	2
ALLANTOIN	INACTIVE INGREDIENT	344S277G0Z	2
AMINOMETHYLPROPANOL	INACTIVE INGREDIENT	LU49E6626Q	2
BUTYLPARABEN	INACTIVE INGREDIENT	3QPI1U3FV8	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	2
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	2
DIMETHICONE	INACTIVE INGREDIENT	92RU3N3Y1O	2
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	2
EMU OIL	INACTIVE INGREDIENT	344821WD61	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
HEXYL LAURATE	INACTIVE INGREDIENT	4CG9F9W01Q	2
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	2
ISOBUTYLPARABEN	INACTIVE INGREDIENT	0QQJ25X58G	2
ISOPROPYLPARABEN	INACTIVE INGREDIENT	A6EOX47QK0	2
LINALOOL, (+/-)-	INACTIVE INGREDIENT	D81QY6I88E	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	2
PEG-40 CASTOR OIL	INACTIVE INGREDIENT	4ERD2076EF	2
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	2
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	2
POLYGLYCERYL-4 ISOSTEARATE	INACTIVE INGREDIENT	820DPX33S7	2
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	2
POTASSIUM CETYL PHOSPHATE	INACTIVE INGREDIENT	03KCY6P7UT	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	2
SODIUM ASCORBATE	INACTIVE INGREDIENT	S033EH8359	2
SODIUM DEHYDROACETATE	INACTIVE INGREDIENT	8W46YN971G	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	2
UREA	INACTIVE INGREDIENT	8W8T17847W	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

Laura Mercier Flawless Skin Mega Moisture Creme Broad Spectrum SPF 15 Sunscreen for Normal/Dry Skin
AVOBENZONE, OCTINOXATE
AVOBENZONE
OCTINOXATE
WATER
CYCLOMETHICONE 5
DIMETHICONE
POLYGLYCERYL-4 ISOSTEARATE
HEXYL LAURATE
EMU OIL
GLYCERIN
SORBITOL
CETOSTEARYL ALCOHOL
PEG-40 CASTOR OIL
.ALPHA.-TOCOPHEROL ACETATE
POTASSIUM CETYL PHOSPHATE
PETROLATUM
POLYSORBATE 60
UREA
HYALURONATE SODIUM
ALLANTOIN
SODIUM ASCORBATE
PHENOXYETHANOL
METHYLPARABEN
EDETATE SODIUM
ISOPROPYLPARABEN
ISOBUTYLPARABEN
BUTYLPARABEN
SODIUM DEHYDROACETATE
AMINOMETHYLPROPANOL
LINALOOL, (+/-)-
PROPYLPARABEN

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
65342-0945	65342-0945-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
AVOBENZONE	G63QQF2NOX	ACTIB
OCTINOXATE	4Y5P7MUD51	ACTIB
WATER	059QF0KO0R	IACT
CYCLOMETHICONE 5	0THT5PCI0R	IACT
DIMETHICONE	92RU3N3Y1O	IACT
POLYGLYCERYL-4 ISOSTEARATE	820DPX33S7	IACT
HEXYL LAURATE	4CG9F9W01Q	IACT
EMU OIL	344821WD61	IACT
GLYCERIN	PDC6A3C0OX	IACT
SORBITOL	506T60A25R	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
PEG-40 CASTOR OIL	4ERD2076EF	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
POTASSIUM CETYL PHOSPHATE	03KCY6P7UT	IACT
PETROLATUM	4T6H12BN9U	IACT
POLYSORBATE 60	CAL22UVI4M	IACT
UREA	8W8T17847W	IACT
HYALURONATE SODIUM	YSE9PPT4TH	IACT
ALLANTOIN	344S277G0Z	IACT
SODIUM ASCORBATE	S033EH8359	IACT
PHENOXYETHANOL	HIE492ZZ3T	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
EDETATE SODIUM	MP1J8420LU	IACT
ISOPROPYLPARABEN	A6EOX47QK0	IACT
ISOBUTYLPARABEN	0QQJ25X58G	IACT
BUTYLPARABEN	3QPI1U3FV8	IACT
SODIUM DEHYDROACETATE	8W46YN971G	IACT
AMINOMETHYLPROPANOL	LU49E6626Q	IACT
LINALOOL, (+/-)-	D81QY6I88E	IACT
PROPYLPARABEN	Z8IX2SC1OH	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 7 · 368 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SORBITOL	SORBITOL	506T60A25R	POWDER, FOR SUSPENSION / ORAL		12000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / NASAL	26 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	SHAMPOO / TOPICAL	1.33 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRADERMAL	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	FILM, EXTENDED RELEASE / TRANSDERMAL	306.2 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRASYNOVIAL	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, EXTENDED RELEASE / ORAL		265 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION/ DROPS / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	SOLUTION / ORAL		6 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, SOLUTION / SUBCUTANEOUS	4.7 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	TABLET, EXTENDED RELEASE / ORAL	0.12 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION / INTRA-ARTICULAR	45 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / AURICULAR (OTIC)	63.64 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE / ORAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	FILM / BUCCAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM ASCORBATE	SODIUM ASCORBATE	S033EH8359	TABLET / ORAL		30 mg	Exact identifier — unii candidate 7 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE / ORAL		3487 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / DENTAL	15 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	LIQUID / TOPICAL	0.02 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, COATED / ORAL	0.8 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	LIQUID / TOPICAL	1 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	ELIXIR / ORAL	833.3 mg		Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
AMINOMETHYLPROPANOL	AMINOMETHYLPROPANOL	LU49E6626Q	LOTION / TOPICAL	0.3 %w/w		Exact identifier — unii candidate 2 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	CREAM / VAGINAL		200 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET / PERIODONTAL	0.53 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	JELLY / VAGINAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SUPPOSITORY / RECTAL	0.05 mg/mg		Exact identifier — unii candidate 13 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SPRAY / NASAL	22.3 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
HYALURONATE SODIUM	HYALURONATE SODIUM	YSE9PPT4TH	LOTION / TOPICAL	0.01 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SOLUTION / INTRAMUSCULAR		45 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 44 equally ranked IID candidates
CYCLOMETHICONE 5	CYCLOMETHICONE 5	0THT5PCI0R	AEROSOL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CAPSULE, EXTENDED RELEASE / ORAL	9.43 mg		Exact identifier — unii candidate 9 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RESPIRATORY (INHALATION)	0.03 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / VAGINAL		6 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / NASAL	250 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, SUSPENSION / SUBCUTANEOUS	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, COATED / ORAL	1 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	FILM, SOLUBLE / BUCCAL		3 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SORBITOL	SORBITOL	506T60A25R	POWDER / ORAL		36000 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	SUSPENSION / TOPICAL	2.85 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, EMULSION / INTRAVENOUS		24100 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
BUTYLPARABEN	BUTYLPARABEN	3QPI1U3FV8	TABLET, EXTENDED RELEASE / ORAL	0.01 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SHAMPOO, SUSPENSION / TOPICAL	0.15 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SOFT TISSUE	0.15 %w/v		Exact identifier — unii candidate 79 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
4b18a53b-983d-737a-e063-6394a90a3a99			fc4806e4-234a-49fc-b205-c25f43db041d	2026-02-18	Warnings	Exact identifier spl set id: fc4806e4-234a-49fc-b205-c25f43db041d

Reported adverse events (FAERS/openFDA)#

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