FDA.reportPublic FDA data

AVOBENZONE, OCTISALATE, OCTOCRYLENE, and OXYBENZONE

Manufacturer
Bel Star S.A. (Colombia)
Effective date
2022-03-08
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:06:44

Label at a glance#

ProductLEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 day facial SPF 15 against noticeable signs of aging all skin types
Active ingredientAVOBENZONE, OCTISALATE, OCTOCRYLENE, OXYBENZONE
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 and evenly 15 minutes before sun exposure. Use a water resistant sunscreen if swimming or sweating. Reapply at least every 2 hours Children under 6 months of age: Ask a doctor 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 protec...

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 IngredientsPurpose
AVOBENZONE 3%Sunscreen
OCTISALATE 5%Sunscreen
OCTOCRYLENE 3%Sunscreen
OXYBENZONE 5%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.

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 swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally and evenly 15 minutes before sun exposure.
  • Use a water resistant sunscreen if swimming or sweating.
  • Reapply at least every 2 hours
  • Children under 6 months of age: Ask a doctor
  • 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.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

WATER, C12-15 ALKYL BENZOATE, CYCLOHEXASILOXANE, GLYCERIN, POTASSIUM CETYL PHOSPHATE, ALBIZIA JULIBRISSIN BARK EXTRACT, DIMETHICONE, GLYCERYL STEARATE, PENTYLENE GLYCOL, METHYL METHACRYLATE CROSSPOLYMER, HYDROGENATED PALM GLYCERIDES, PHENOXYETHANOL, XANTHAN GUM, C20-22 ALKYL PHOSPHATE, ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER, FRAGRANCE, C20-22 ALCOHOLS, CHLORPHENESIN, HYDROLYZED CERATONIA SILIQUA SEED EXTRACT, SODIUM HYDROXIDE, ACACIA SENEGAL GUM, DISODIUM EDTA, OLIVE OIL AMINOPROPANEDIOL ESTERS, RASPBERRY SEED OIL/TOCOPHERYL SUCCINATE AMINOPROPANEDIOL ESTERS, HYDROXYPROPYL CYCLODEXTRIN, PALMITOYL TRIPEPTIDE-38.

SPL UNCLASSIFIED SECTION

Dist. by Ventura Int Ltd. DBA Belcorp USA, Miami, FL
33126

PRINCIPAL DISPLAY PANEL - 50 ml Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEDERM

DAY LOTION

SUNSCREEN
BROAD SPECTRUM
SPF 15

day facial lotion
SPF 15 against
noticeable signs
of aging
all skin types

50 ml e (1.6 fl.oz.)

PRINCIPAL DISPLAY PANEL - 50 ml Bottle BoxPRINCIPAL DISPLAY PANEL - 50 ml Bottle Box

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
14141-136-022022-03-08C16284748780-1d6a99b39-9f61-a426-e053-dadaa90af4c2LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 day facial SPF 15 against noticeable signs of aging all skin types
14141-136-022022-01-28C16284748780-1d6a99b39-9f61-a426-e053-dadaa90af4c2LEDERM DAY SUNSCREEN BROAD SPECTRUM SPF 15 day facial SPF 15 against noticeable signs of aging all skin types

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
14141-13614141-136-01, 14141-136-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CYCLOMETHICONE 6XHK3U310BAIACT
GLYCERINPDC6A3C0OXIACT
POTASSIUM CETYL PHOSPHATE03KCY6P7UTIACT
ALBIZIA JULIBRISSIN BARK0J9G6W44DVIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PENTYLENE GLYCOL50C1307PZGIACT
HYDROGENATED PALM GLYCERIDESYCZ8EM144QIACT
PHENOXYETHANOLHIE492ZZ3TIACT
XANTHAN GUMTTV12P4NEEIACT
C20-22 ALKYL PHOSPHATEL4VKP0Y7RPIACT
C20-22 ALCOHOLSO4M0347C6AIACT
CHLORPHENESINI670DAL4SZIACT
SODIUM HYDROXIDE55X04QC32IIACT
ACACIA5C5403N26OIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
PALMITOYL LYSYLDIOXYMETHIONYLLYSINET7A529FB8OIACT
AVOBENZONEG63QQF2NOXACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB

Source Document#

Source XML

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
d9ba8886-f3cc-be9e-e053-2a95a90aceda2e8c87df-d8d4-488c-bb04-fd4602b36e392022-03-08WarningsExact identifier
spl id: d9ba8886-f3cc-be9e-e053-2a95a90aceda
spl set id: 2e8c87df-d8d4-488c-bb04-fd4602b36e39

Reported adverse events (FAERS/openFDA)#

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