FDA.reportPublic FDA data

Suntone

Manufacturer
Prime Enterprises Inc.
Effective date
2020-01-17
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:03:17

Label at a glance#

ProductSuntone Kids Broad Spectrum SPF 50 Sunscreen
Active ingredientAVOBENZONE, HOMOSALATE, 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 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 broad spectrum SPF of 15 or higher and other sun protection measures including: limit time in the sun, es...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Avobenzone 3%

Homosalate 10%

Octisalate 5%

Octocrylene 2.75%

Oxybenzone 3%

Purpose

OTC - PURPOSE SECTION

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 - ASK DOCTOR 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 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 broad spectrum SPF 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-sleeve shirts, pants, hats, and sunglasses
  • children under 6 months: Ask a doctor

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

OTHER SAFETY INFORMATION

  • protect this product from excesive heat and direct sun

Questions or Comments?

OTC - QUESTIONS SECTION

Biocycle Laboratories. Inc.

16363 NW 49 Avenue, Miami, FL 33014

SUntone Kids Broad Spectrum SPF 50 Sunscreen

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Principal Display ImagePrincipal Display Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58443-0138-42023-01-30C16284748780-1f386c64a-2b9f-0266-e053-dadaa90a7c1aSuntone Kids Broad Spectrum SPF 50 Sunscreen

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58443-0138-4SuntoneKids Broad Spectrum SPF 50 Sunscreen177 mL in 1 TUBELOTION1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58443-0138SUNTONE KIDS BROAD SPECTRUM SPF 50 SUNSCREEN (AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, AND OXYBENZONE) LOTION [PRIME ENTERPRISES INC.]3Legacy NDC, 1 package rows20200121_2b86fb9f-3eac-533b-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58443-013858443-0138-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLPARABENZ8IX2SC1OHIACT
ISOPROPYLPHTHALIMIDE1J1MM83329IACT
COCOA BUTTER512OYT1CRRIACT
EDETATE DISODIUM7FLD91C86KIACT
HYPROMELLOSES3NXW29V3WOIACT
HIGH DENSITY POLYETHYLENEUG00KM4WR7IACT
POLYSORBATE 207T1F30V5YHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITAN MONOOLEATE06XEA2VD56IACT
CARBOMER 9404Q93RCW27EIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ALOE VERA LEAFZY81Z83H0XIACT
(C10-C30)ALKYL METHACRYLATE ESTERXH2FQZ38D8IACT
TROLAMINE9O3K93S3TKIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
WATER059QF0KO0RIACT
N-BUTYLPHTHALIMIDE5TH1DKT35EIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
AVOBENZONEG63QQF2NOXACTIB
HOMOSALATEV06SV4M95SACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
OXYBENZONE95OOS7VE0YACTIB
METHYLPARABENA2I8C7HI9TIACT

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
9c5a9ebc-5cae-7b1a-e053-2a95a90aad132b86fb9f-3eac-533b-e054-00144ff8d46c2020-01-17WarningsExact identifier
spl id: 9c5a9ebc-5cae-7b1a-e053-2a95a90aad13
spl set id: 2b86fb9f-3eac-533b-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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