PRO LASER

Manufacturer
Zenith Medicosm SL
Effective date
2012-05-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:32:03

Label at a glance#

ProductPRO LASER BODY
Active ingredientOCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE
Label structure4 sections

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%

Titanium Dioxide 25%

Oxybenzone 6%

Description

DESCRIPTION SECTION

PRO LASER BODY EMULSION

SPF 35

Protective body cream formulated with the perfect combination of sunscreens capable of covering a larger area of the solar radiation spectrum.  Indicated for use after laser body treatments and surgery, and for skin that has been subjected to aggressive treatments and that needs extreme protection and rapid regeneration

Apply by rubbing into the skin until completely absorbed. Repeat 2 to 3 times a day. Not water resistant.

150ml. 5.1 fl. Oz

Warning

WARNINGS SECTION

TOPICAL USE

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PROLAS
PROLAS

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
42248-130-012019-11-13C16284748780-197449f38-d3e5-f6ea-e053-dbdaa90aa703Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42248-130-01PRO LASERBODY150 mL in 1 BOTTLECREAM1501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42248-130PRO LASER BODY (OCTINOXATE, TITANIUM DIOXIDE, OXYBENZONE) CREAM [ZENITH MEDICOSM SL]1Legacy NDC, 1 package rows20120524_bfa5d2c4-9b40-491c-ab80-cb9c84d9e680.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
OCTINOXATEACTIVE INGREDIENT4Y5P7MUD511
OXYBENZONEACTIVE INGREDIENT95OOS7VE0Y1
TITANIUM DIOXIDEACTIVE INGREDIENT15FIX9V2JP1
OCTINOXATEACTIVE MOIETY4Y5P7MUD511
OXYBENZONEACTIVE MOIETY95OOS7VE0Y1
TITANIUM DIOXIDEACTIVE MOIETY15FIX9V2JP1
(2-CARBETHOXYETHYL)DIETHOXY(METHYL)SILANEINACTIVE INGREDIENTN28HAC3H5P1
ALPHA-TOCOPHEROL ACETATEINACTIVE INGREDIENT9E8X80D2L01
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O69331
ASPARTIC ACIDINACTIVE INGREDIENT30KYC7MIAI1
BUTYLPARABENINACTIVE INGREDIENT3QPI1U3FV81
CARBOMER 934INACTIVE INGREDIENTZ135WT92081
COCONUT ACIDINACTIVE INGREDIENT40U37V505D1
COLLAGEN, SOLUBLE, FISH SKININACTIVE INGREDIENT8JC99XGU4W1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
ETHYLPARABENINACTIVE INGREDIENT14255EXE391
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE41
HYDROGENATED SOYBEAN LECITHININACTIVE INGREDIENTH1109Z9J4N1
HYDROLYZED ELASTIN, BOVINE, ALKALINE (1000 MW)INACTIVE INGREDIENTZR28QKN0WT1
HYDROXYPROLINEINACTIVE INGREDIENTRMB44WO89X1
IMIDUREAINACTIVE INGREDIENTM629807ATL1
ISOBUTYLPARABENINACTIVE INGREDIENT0QQJ25X58G1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
METHYLPARABEN SODIUMINACTIVE INGREDIENTCR6K9C2NHK1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999R1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3T1
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SODIUM POLYACRYLATE (8000 MW)INACTIVE INGREDIENT285CYO341L1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1
WHITE WAXINACTIVE INGREDIENT7G1J5DA97F1

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
42248-13042248-130-01

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 8 · 421 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE, LIQUID FILLED / ORAL185 mgExact identifier — unii candidate
75 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHPASTE, DENTIFRICE / DENTALNAExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / OPHTHALMIC0.01 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TELIXIR / ORAL800 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / ORAL1 mg/1mlExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / ORAL432 mgExact identifier — unii candidate
77 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SYRUP / ORAL28.4 mg/1mlExact identifier — unii candidate
15 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCREAM / TOPICAL500 mgExact identifier — unii candidate
15 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4CREAM / TOPICAL836 mgExact identifier — unii candidate
21 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / INTRAVENOUS0.03 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4TABLET / SUBLINGUAL1.23 mgExact identifier — unii candidate
21 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM, AUGMENTED / TOPICAL20 mgExact identifier — unii candidate
22 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVASCULAR0.48 mgExact identifier — unii candidate
77 equally ranked IID candidates
PHENOXYETHANOLPHENOXYETHANOLHIE492ZZ3TLOTION / TOPICAL1 %w/wExact identifier — unii candidate
6 equally ranked IID candidates
COCONUT ACIDCOCONUT ACID40U37V505DSHAMPOO / TOPICAL3 %w/wExact identifier — unii candidate
3 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHINJECTION, SOLUTION / INTRAVENOUS5 mgExact identifier — unii candidate
68 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / EPIDURAL30 mgExact identifier — unii candidate
79 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSOLUTION / TOPICALNAExact identifier — unii candidate
22 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / NASAL0.1 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4AEROSOL, FOAM / TOPICAL3.27 %w/wExact identifier — unii candidate
21 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / IONTOPHORESIS0.1 %w/vExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION / EPIDURAL1 mgExact identifier — unii candidate
79 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKSOAP / TOPICAL0.08 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / AURICULAR (OTIC)0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCAPSULE / ORAL3487 mgExact identifier — unii candidate
75 equally ranked IID candidates
BUTYLPARABENBUTYLPARABEN3QPI1U3FV8SOLUTION / ORAL6 mgExact identifier — unii candidate
15 equally ranked IID candidates
ALPHA-TOCOPHEROL ACETATE.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0CAPSULE / ORAL2 mgExact identifier — unii candidate
3 equally ranked IID candidates
WHITE WAXWHITE WAX7G1J5DA97FCAPSULE, EXTENDED RELEASE / ORAL71 mgExact identifier — unii candidate
15 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSOLUTION / TOPICAL24 mgExact identifier — unii candidate
68 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION/ DROPS / OPHTHALMIC0.13 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / VAGINAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
ASPARTIC ACIDASPARTIC ACID30KYC7MIAIINJECTION / INTRAVENOUS22 mgExact identifier — unii candidate
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INFILTRATION6 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRABURSAL0.01 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, FILM COATED / ORAL1.55 mgExact identifier — unii candidate
75 equally ranked IID candidates
METHYLPARABEN SODIUMMETHYLPARABEN SODIUMCR6K9C2NHKPOWDER, FOR SUSPENSION / ORAL80 mgExact identifier — unii candidate
6 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / VAGINAL56 mgExact identifier — unii candidate
22 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TSOLUTION / OPHTHALMIC0.05 %w/wExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM / TOPICAL1720 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSPRAY, METERED / NASAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TRANSDERMAL6 mgExact identifier — unii candidate
22 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TCREAM / VAGINAL22 mgExact identifier — unii candidate
79 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TINJECTION, SOLUTION / INTRAVENOUS45 mgExact identifier — unii candidate
79 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSHAMPOO, SUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TOINTMENT / TOPICAL29 mgExact identifier — unii candidate
79 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / NASAL25 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRACARDIAC2 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYSTEM / TOPICAL21 mgExact identifier — unii candidate
68 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERYL MONOSTEARATEGLYCERYL MONOSTEARATE230OU9XXE4GRANULE, FOR SUSPENSION / ORAL4 mgExact identifier — unii candidate
21 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TDROPS / NASAL26 mgExact identifier — unii candidate
79 equally ranked IID candidates
CARBOMER 934CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Z135WT9208SUSPENSION / ORAL288 mgExact identifier — unii candidate
14 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KEMULSION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHSYRUP / ORAL40 mgExact identifier — unii candidate
68 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
84f78d03-09df-4ca4-ab2e-e7bac2e6551ebfa5d2c4-9b40-491c-ab80-cb9c84d9e6802012-05-23WarningsExact identifier
spl id: 84f78d03-09df-4ca4-ab2e-e7bac2e6551e
spl set id: bfa5d2c4-9b40-491c-ab80-cb9c84d9e680

Reported adverse events (FAERS/openFDA)#

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