FDA.reportPublic FDA data

Mimosa Lane SPF45

Manufacturer
R&G Divergency LLC | Swiss-American CDMO, LLC
Effective date
2026-01-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:34:35

Label at a glance#

ProductMimosa Lane SPF45
Active ingredientOCTINOXATE, OCTISALATE, ZINC OXIDE
Label structure10 sections

Indications and uses

Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Dosage and administration

Apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating, immediately after towel drying and 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 of 15 or higher and other sun protection measures including: limit time in th...

Label contents#

Full prescribing information#

Warnings

WARNINGS SECTION

For external use only. Do not use on damaged or broken skin. When using this product keep out of eyes. Rinse with water to remove. Stop use and ask a physician if rash occurs. If product is swallowed get medical help or contact a Poison Control Center right away.

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%
Octisalate 3.0%
Zinc Oxide 8.0%

Indications and Usage

INDICATIONS & USAGE SECTION

Helps prevent sunburn. If used as directed with other sun protection measure (See Directions), decreases the risk of skin cancer and early skin aging caused by the sun.

Purpose

OTC - PURPOSE SECTION

Sunscreen

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

Apply liberally 15 minutes before sun exposure. Reapply: after 80 minutes of swimming or sweating, immediately after towel drying and 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 of 15 or higher and other sun protection measures including: limit time in the sun, especially from 10 am to 2 pm. Wear long-sleeve shirts, pants, hats, and sunglasses. Children under 6 months: ask a physician.

Other information

OTHER SAFETY INFORMATION

Protect this product from excessive heat and direct sun.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, cyclopentasiloxane, ethylhexyl isononanoate, butylene glycol, lauryl PEG-9 polydimethylsiloxyethyl dimethicone, dimethicone, phenoxyethanol, sodium chloride, triethoxycaprylylsilane, dimethicone/PEF-10/15 crosspolymer, dimethicone/vinyl dimethicone crosspolymer, sodium hyaluronate, iodopropynyl butylcarbamate, ascorbyl palmitate, retinyl palmitate, tocopherol

Questions

OTC - QUESTIONS SECTION

Call toll free 1-844-940-2918
Email: contact@mimosalane.com

Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Mimosa Lane UC ArtworkMimosa Lane UC Artwork

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ZINC CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84554-0006-1Mimosa Lane SPF45150 g in 1 TUBECREAM1503

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
84554-000684554-0006-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
BUTYLENE GLYCOL3XUS85K0RAIACT
PHENOXYETHANOLHIE492ZZ3TIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
HYALURONIC ACIDS270N0TRQYIACT
CYCLOMETHICONENMQ347994ZIACT
ASCORBYL PALMITATEQN83US2B0NIACT
VITAMIN A PALMITATE1D1K0N0VVCIACT
DIMETHICONE/PEG-10/15 CROSSPOLYMER21AS8B1BSSIACT
DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE)9E4CO0W6C5IACT
LAURYL PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE25G622K2RAIACT
ETHYLHEXYL ISONONANOATEI6KB4GE3K4IACT
TOCOPHEROLR0ZB2556P8IACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
ZINC OXIDESOI2LOH54ZACTIM

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
Mimosa Lane SPF45OCTINOXATE, OCTISALATE, ZINC OXIDE SUNSCREENR&G Divergency LLC40f3b8ea-bfa5-4c66-9c79-c4408bda857a2026-01-24WarningsExact identifier
ndc (package): 84554-0006-1
ndc (product): 84554-0006
ndc11 (package): 84554000601
spl id: 4927bdbf-b986-aa67-e063-6394a90aac39
spl set id: 40f3b8ea-bfa5-4c66-9c79-c4408bda857a

Reported adverse events (FAERS/openFDA)#

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