FDA.reportPublic FDA data

BISABOLOL - Elysium Consumer Healthcare LLC | Voyant Beauty

Manufacturer
Elysium Consumer Healthcare LLC | Voyant Beauty
Effective date
2025-08-29
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:12:25

Label at a glance#

ProductPurpose Dual Treatment SPF 10
Active ingredientOXYBENZONE, OCTINOXATE, OCTISALATE
Label structure13 sections

Indications and uses

helps prevent sunburn

Dosage and administration

apply generously and evenly 15 minutes before sun exposure apply to all skin exposed to the sun use a water reistant sunscreen if swimming or sweating reapply at least every 2 hours children un 6 months of age: Ask a doctor

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%, Octisalate 5%, Oxybenzone 3%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

helps prevent sunburn

Warnings

WARNINGS SECTION

Skin Cancer/Skin Aging Alert: Spending time in the sun increases your risk of skin cancer and ealy skin aging. This product has been shown only to help prevent sunburn, not skin cancer or early skin aging.

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 poduct is swallowed, get medical help or contact a Poison Contro Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • apply generously and evenly 15 minutes before sun exposure
  • apply to all skin exposed to the sun
  • use a water reistant sunscreen if swimming or sweating
  • reapply at least every 2 hours
  • children un 6 months of age: Ask a doctor

Other information

OTHER SAFETY INFORMATION

  • protect this product from excesssive heat and direct sun
  • may stain or damge som farics or surfaces

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, octyldodecyl neopentanoate, glycerin, emulsifying wax NF, glyceryl stearate, PEG-100 stearate, dimethicone, triethanolamine, diazolidinyl urea, carbomer, methylparaben, ethylparaben, propylparaben, bisabolol, farnesol, citric acid

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-553-5340

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Purpose

Dual Treatment Mosture Lotion

Sunscreen SPF 10

Oil-Free

Fragrance Free

Provides Long-Lasting Moisture

Developed with Dermatologists

PurposePurpose

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87033-2000-1Purpose Dual Treatment SPF 101 in 1 CARTONLOTION11
87033-2000-1Purpose Dual Treatment SPF 10113 g in 1 BOTTLE, PLASTICLOTION1131

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
87033-200087033-2000-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISABOLOL24WE03BX2TIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
OCTYLDODECYL NEOPENTANOATEX8725R883TIACT
SYNTHETIC WAX (1900 MW)5M631N9V0SIACT
PEG-100 STEARATEYD01N1999RIACT
TRIETHANOLAMINE9O3K93S3TKIACT
PROPYLPARABENZ8IX2SC1OHIACT
OXYBENZONE95OOS7VE0YACTIB
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
METHYLPARABENA2I8C7HI9TIACT
CITRIC ACID2968PHW8QPIACT
FARNESOLEB41QIU6JLIACT
OCTINOXATE4Y5P7MUD51ACTIB
ETHYLPARABEN14255EXE39IACT
GLYCERINPDC6A3C0OXIACT
CARBOMER0A5MM307FCIACT
OCTISALATE4X49Y0596WACTIB
DIMETHICONE92RU3N3Y1OIACT
WATER059QF0KO0RIACT

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
Purpose Dual Treatment SPF 10OCTINOXATE 7.5%, OCTISALATE 5%, OXYBENZONE 3%Elysium Consumer Healthcare LLC3d7fe711-a671-df30-e063-6394a90afbbf2025-08-29WarningsExact identifier
ndc (package): 87033-2000-1
ndc (product): 87033-2000
ndc11 (package): 87033200001
spl id: 3d7fe711-a672-df30-e063-6394a90afbbf
spl set id: 3d7fe711-a671-df30-e063-6394a90afbbf

Reported adverse events (FAERS/openFDA)#

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