FDA.reportPublic FDA data

Solmate Sunscreen Lotion Broad Spectrum SPF 30

Manufacturer
Prime Enterprises Inc.
Effective date
2020-10-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:32:09

Label at a glance#

ProductSolmate Sunscreen Broad Spectrum SPF 30
Active ingredientOCTOCRYLENE, HOMOSALATE, OCTISALATE, AVOBENZONE, OXYBENZONE
Label structure8 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 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying 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, ...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%, Homosalate 7.5%, Octisalate 5%, Octocrylene 2.75%, Oxybenzone 2%

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

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

OTC - STOP USE SECTION

if rash occurs

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

apply liberally 15 minutes before sun exposure

reapply:

  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • 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 form 10 a.m. - 2 p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses

children under 6 months: Ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aloe Barbadensis Leaf Juice, Butylphthalimide, C12-15 Alkyl Benzoate, Carbomer, Disodium EDTA, Fragrance (Parfum), Hydroxypropyl Methylcellulose, Isopropylphthalimide, Methylisothiazolinone, Methylparaben, Polyethylene, Polysorbate 20, Propylene Glycol, Propylparaben, Sorbitan Oleate, Theobroma Cacao (Cocoa) Seed Butter, Tocopheryl Acetate, Triethanolamine, Water (Aqua)

Other information

SPL UNCLASSIFIED SECTION

protect ths product from excessive heat and direct sun

Questions or comments?:

OTC - QUESTIONS SECTION

Biocycle Laboratories, Inc. 16363 NW 49 Avenue, Miami, FL 33014

Sol Mate SPF 30 Lotion

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display LabelPrincipal Display Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0170-42024-01-30C16284748780-11030e365-5040-111a-e063-dadaa90a10e2Solmate Sunscreen Lotion Broad Spectrum SPF 30

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0170-4SolmateSunscreen Broad Spectrum SPF 30177 mL in 1 TUBELOTION1771

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0170SOLMATE SUNSCREEN BROAD SPECTRUM SPF 30 (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]1Legacy NDC, 1 package rows20201021_b21e43ff-dfe8-6679-e053-2a95a90a4d3c.zip

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-017058443-0170-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
FRAGRANCE LAVENDER & CHIA F-153480SXS9CO2TZKIACT
ALOE VERA LEAFZY81Z83H0XIACT
OCTOCRYLENE5A68WGF6WMACTIB
METHYLISOTHIAZOLINONE229D0E1QFAIACT
N-BUTYLPHTHALIMIDE5TH1DKT35EIACT
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
ISOPROPYLPHTHALIMIDE1J1MM83329IACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
TROLAMINE9O3K93S3TKIACT
AVOBENZONEG63QQF2NOXACTIB
WATER059QF0KO0RIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
POLYSORBATE 207T1F30V5YHIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
HYPROMELLOSES3NXW29V3WOIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
OXYBENZONE95OOS7VE0YACTIB
COCOA BUTTER512OYT1CRRIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT

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
b21e4467-a8a2-7118-e053-2a95a90a9c2bb21e43ff-dfe8-6679-e053-2a95a90a4d3c2020-10-20WarningsExact identifier
spl id: b21e4467-a8a2-7118-e053-2a95a90a9c2b
spl set id: b21e43ff-dfe8-6679-e053-2a95a90a4d3c

Reported adverse events (FAERS/openFDA)#

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