Avobenzone, Homosalate, Octisalate, and Octocrylene

Manufacturer
Beauty Manufacturing Solutions Corp.
Effective date
2022-12-06
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:52:24

Label at a glance#

ProductLOreal Paris Revitalift Derm Intensives Invisible UV Fluid Broad Spectrum SPF 50 Sunscreen
Active ingredientHOMOSALATE, OCTISALATE, AVOBENZONE, OCTOCRYLENE
Label structure13 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: shake well apply liberally 15 minutes before sun exposure reapply at least every 2 hours use a water resistant sunscreen if swimming or sweating 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: limi...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 15%

Octisalate 5%

Octocrylene 10%

OTC - PURPOSE SECTION

Avobenzone 3%-Sunscreen

Homosalate 15%-Sunscreen

Octisalate 5%-Sunscreen

Octocrylene 10%-Sunscreen

USES

INSTRUCTIONS FOR USE 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 SECTION

For external use only

FLAMMABLE UNTIL DRY.

WARNINGS SECTION

Do not use near fire, flame, or heat.

OTC - DO NOT USE SECTION

on damaged or broken skin

OTC - WHEN USING SECTION

keep out of eyes. Rinse with water to remove.

OTC - STOP USE SECTION

rash occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS

INSTRUCTIONS FOR USE SECTION

For sunscreen use:

shake well
apply liberally 15 minutes before sun exposure
reapply at least every 2 hours
use a water resistant sunscreen if swimming or sweating
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

OTHER SAFETY INFORMATION

protect the product in this container from excessive heat and direct sun

INACTIVE INGREDIENT SECTION

water, alcohol denat.,glycerin, styrene/acrylates copolymer dimethicone, butyloctyl salicylate,silica, Isononyl Isononanoate,Isopropyl Myristate, Cetearyl Alcohol, Calcium Aluminum Borosilicate,Tocopherol,Adenosine,Phenyl Resorcinol,Trisodium Ethylenediamine Disuccinate,Ascorbyl Glucoside,isocetyl stearate,ammonium acryloyldimethyltaurate/vp copolymer,caprylyl glycol,carbomer,cetearyl glucoside, inulin lauryl carbamate,Lecithin,PEG-20,PEG-8 laurate,pullulan,sclerotium gum,sodium dodecylbenzenesulfonate, Sodium Stearoyl Glutamate,t-Butyl Alcohol,Xanthan Gum,Phenoxyethanol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principle Display PanelPrinciple Display Panel

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d676a241-be05-4740-b3ee-1a5f2ed422d2Product name420180615
dd8bd48f-20d6-43c7-b471-3ae872868afaProduct name320180125
d41954ff-bc63-4b2c-aba0-9146707659d7Product name220151117

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11090-099-012025-01-30C16284748780-12cef2736-6e47-d83d-e063-dadaa90ab31fLOreal Paris Revitalift Derm Intensives Invisible UV Fluid Broad Spectrum SPF 50 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11090-099-01LOreal Paris Revitalift Derm Intensives Invisible UV Fluid Broad Spectrum SPF 50 Sunscreen50 mL in 1 BOTTLEGEL501
11090-099-01LOreal Paris Revitalift Derm Intensives Invisible UV Fluid Broad Spectrum SPF 50 Sunscreen1 in 1 CARTONGEL11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11090-099LOREAL PARIS REVITALIFT DERM INTENSIVES INVISIBLE UV FLUID BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, AND OCTOCRYLENE) GEL [BEAUTY MANUFACTURING SOLUTIONS CORP.]1Legacy NDC, 2 package rows20221211_ef2c1165-5554-1cce-e053-2a95a90a0f45.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11090-09911090-099-01

Ingredients#

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

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

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
ef2c1165-5555-1cce-e053-2a95a90a0f45ef2c1165-5554-1cce-e053-2a95a90a0f452022-12-06WarningsExact identifier
spl id: ef2c1165-5555-1cce-e053-2a95a90a0f45
spl set id: ef2c1165-5554-1cce-e053-2a95a90a0f45

Reported adverse events (FAERS/openFDA)#

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