AVOBENZONE, OCTINOXATE

Manufacturer
Gurwitch Products, L.L.C. | Atlantis Laboratories, Inc. | Beauty Manufacturing Solutions Corp.
Effective date
2015-07-14
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 Tinted Moisturizer - Illuminating Broad Spectrum SPF 20 Sunscreen - Bronze Radiance
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...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Avobenzone (2.0%), Octinoxate (7.5%)

Purpose

OTC - PURPOSE SECTION

Sunscreen

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, dimethicone, cetearyl alcohol, hydrogenated polyisobutene, xylitylglucoside, PEG-40 castor oil, polyglyceryl-4 isostearate, cyclopentasiloxane, potassium cetyl phosphate, hexyl laurate, anhydroxylitol, mica, tocopheryl acetate, cetyl PEG/PPG-10/1 dimethicone, xylitol, polysorbate 60, phenoxyethanol, butylene glycol, tribhenin, sodium dehydroacetate, sodium hyaluronate, allantoin, camellia sinensis leaf extract, copper gluconate, carbomer, hydrogenated olive oil, butyrospermum parkii (shea) butter, aminomethyl propanol, tetrasodium EDTA, magnesium aluminum silicate, sodium ascorbate, dipotassium glcyrrhizate, may contain: titanium dioxide, iron oixides, copper powder.

Questions or comments?

OTC - QUESTIONS SECTION

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

Product Labels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageTubeTube

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
65342-1394-02020-01-31C16284748780-19d75b9d0-c9d0-f424-e053-dadaa90a57ceLaura Mercier Tinted Moisturizer - Illuminating Broad Spectrum SPF 20 Sunscreen - Bronze Radiance

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65342-1394LAURA MERCIER TINTED MOISTURIZER - ILLUMINATING BROAD SPECTRUM SPF 20 SUNSCREEN - BRONZE RADIANCE (AVOBENZONE, OCTINOXATE) CREAM [GURWITCH PRODUCTS, L.L.C.]2Legacy NDC20150724_24a0286d-429d-470e-bd7c-89db40a1a960.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
AVOBENZONEACTIVE INGREDIENTG63QQF2NOX2
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD512
AVOBENZONEACTIVE MOIETYG63QQF2NOX2
OCTINOXATEACTIVE MOIETY4Y5P7MUD512
.ALPHA.-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L02
ALLANTOININACTIVE INGREDIENT344S277G0Z2
AMINOMETHYLPROPANOLINACTIVE INGREDIENTLU49E6626Q2
ANHYDROXYLITOLINACTIVE INGREDIENT8XWR7NN42F2
BUTYLENE GLYCOLINACTIVE INGREDIENT3XUS85K0RA2
COPPERINACTIVE INGREDIENT789U1901C52
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R2
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O2
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LU2
GREEN TEA LEAFINACTIVE INGREDIENTW2ZU1RY8B02
HEXYL LAURATEINACTIVE INGREDIENT4CG9F9W01Q2
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH2
HYDROGENATED OLIVE OILINACTIVE INGREDIENT53839415GI2
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NC2
MICAINACTIVE INGREDIENTV8A1AW08802
PEG-40 CASTOR OILINACTIVE INGREDIENT4ERD2076EF2
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T2
POLYGLYCERYL-4 ISOSTEARATEINACTIVE INGREDIENT820DPX33S72
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M2
POTASSIUM CETYL PHOSPHATEINACTIVE INGREDIENT03KCY6P7UT2
SHEANUT OILINACTIVE INGREDIENTO88E196QRF2
SODIUM ASCORBATEINACTIVE INGREDIENTS033EH83592
SODIUM DEHYDROACETATEINACTIVE INGREDIENT8W46YN971G2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2
WATERINACTIVE INGREDIENT059QF0KO0R2
XYLITOLINACTIVE INGREDIENTVCQ006KQ1E2
XYLITYLGLUCOSIDEINACTIVE INGREDIENTO0IEZ166FB2

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65342-139465342-1394-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 29 matching rows.

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 3 · 124 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
XYLITOLXYLITOLVCQ006KQ1ETABLET, ORALLY DISINTEGRATING / ORAL360 mgExact identifier — unii candidate
12 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MCREAM / VAGINAL200 mgExact identifier — unii candidate
13 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSYSTEM / TOPICAL420 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL42 mgExact identifier — unii candidate
40 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET, EXTENDED RELEASE / ORAL2752 mgExact identifier — unii candidate
12 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSHAMPOO / TOPICAL1.33 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TCREAM / TOPICAL57 mgExact identifier — unii candidate
6 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MAEROSOL, FOAM / TOPICAL30 mgExact identifier — unii candidate
13 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSUSPENSION/ DROPS / ORAL4.15 mg/2.5mlExact identifier — unii candidate
17 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCTABLET, CHEWABLE / ORAL12 mgExact identifier — unii candidate
17 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSYRUP / ORAL100 mg/1mlExact identifier — unii candidate
17 equally ranked IID candidates
SODIUM ASCORBATESODIUM ASCORBATES033EH8359INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS0.5 mgExact identifier — unii candidate
7 equally ranked IID candidates
.ALPHA.-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0TABLET / ORAL0.5 mgExact identifier — unii candidate
3 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MLOTION / TOPICAL5 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MTABLET, COATED / ORALNAExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM ASCORBATESODIUM ASCORBATES033EH8359INJECTION, POWDER, FOR SOLUTION / INTRADERMAL0.5 mgExact identifier — unii candidate
7 equally ranked IID candidates
SODIUM ASCORBATESODIUM ASCORBATES033EH8359INJECTION, SOLUTION / INTRAVENOUS29 mgExact identifier — unii candidate
7 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET / ORAL15.04 mgExact identifier — unii candidate
12 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM, SOLUBLE / BUCCAL11 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPOWDER / ORAL2 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET / ORAL232 mgExact identifier — unii candidate
40 equally ranked IID candidates
SODIUM ASCORBATESODIUM ASCORBATES033EH8359SUSPENSION, EXTENDED RELEASE / ORAL33 mgExact identifier — unii candidate
7 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSHAMPOO, SUSPENSION / TOPICAL3 %w/vExact identifier — unii candidate
40 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSHAMPOO / TOPICAL14.55 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING / ORAL6 mgExact identifier — unii candidate
40 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EPASTE / ORAL180 mgExact identifier — unii candidate
12 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCTABLET, EXTENDED RELEASE / ORAL70 mgExact identifier — unii candidate
17 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCLIQUID / ORAL82 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
BUTYLENE GLYCOLBUTYLENE GLYCOL3XUS85K0RASYSTEM / TRANSDERMAL8.12 mgExact identifier — unii candidate
2 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUCAPSULE / ORAL1 mgExact identifier — unii candidate
12 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TAEROSOL / TOPICAL1.05 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSOAP / TOPICAL1 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGUM, CHEWING / BUCCAL182 mgExact identifier — unii candidate
40 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RAEROSOL, FOAM / TOPICAL144 mgExact identifier — unii candidate
3 equally ranked IID candidates
CYCLOMETHICONE 5CYCLOMETHICONE 50THT5PCI0RCREAM, AUGMENTED / TOPICAL260 mgExact identifier — unii candidate
3 equally ranked IID candidates
SODIUM ASCORBATESODIUM ASCORBATES033EH8359CAPSULE / ORAL6 mgExact identifier — unii candidate
7 equally ranked IID candidates
SODIUM ASCORBATESODIUM ASCORBATES033EH8359TABLET / ORAL30 mgExact identifier — unii candidate
7 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MOINTMENT / TOPICAL2 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
EDETATE SODIUMEDETATE SODIUMMP1J8420LUSPONGE / TOPICAL0.14 %w/wExact identifier — unii candidate
12 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE, DENTIFRICE / DENTAL0.4 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCCAPSULE / ORAL60 mgExact identifier — unii candidate
17 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPGRANULE, FOR SUSPENSION / ORAL143 mgExact identifier — unii candidate
40 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRAVITREAL23 mgExact identifier — unii candidate
5 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
40 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSUSPENSION / RECTAL14480 mgExact identifier — unii candidate
17 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET, FILM COATED, EXTENDED RELEASE / ORAL72 mgExact identifier — unii candidate
12 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TGEL / TOPICAL14 mgExact identifier — unii candidate
6 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE PELLETS / ORAL24 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED PELLETS / ORAL4.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EGUM, CHEWING / BUCCAL11915 mgExact identifier — unii candidate
12 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, COATED / ORAL49 mgExact identifier — unii candidate
40 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCSUSPENSION / ORAL5000 mg/5mlExact identifier — unii candidate
17 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUSPENSION / TOPICAL2.85 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
MAGNESIUM ALUMINUM SILICATEMAGNESIUM ALUMINUM SILICATE6M3P64V0NCCREAM / TOPICAL3 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESOLUTION / ORAL21600 mgExact identifier — unii candidate
12 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii candidate
5 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, DELAYED RELEASE / ORAL55 mgExact identifier — unii candidate
40 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPSUPPOSITORY, EXTENDED RELEASE / INTRAUTERINE1 mgExact identifier — unii candidate
40 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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4b2870fb-2efd-00f3-e063-6394a90ad20c24a0286d-429d-470e-bd7c-89db40a1a9602026-02-19WarningsExact identifier
spl set id: 24a0286d-429d-470e-bd7c-89db40a1a960

Reported adverse events (FAERS/openFDA)#

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