SUN CONTROL BROAD SPECTRUM SPF 30

Manufacturer
SKINPLAN.US LLC
Effective date
2024-04-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:11:18

Label at a glance#

ProductSUN CONTROL BROAD SPECTRUM SPF 30
Active ingredientHOMOSALATE, OCTISALATE, ZINC OXIDE
Label structure8 sections

Indications and uses

Helps to 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 and as needed. Children under 6 months of age: ask a doctor. Reapply at least every 2 hours Use 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 the risk, regularly use a sunscreen with broad spectrum SPF of 15 or higher and other sun protection meas...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Homosalate 7%,

Octisalate 5%,

Zinc oxide 6%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

  • Helps to 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 if 

OTC - STOP USE SECTION

rash or irritation develops and last.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Apply liberally 15 minutes before sun exposure and as needed.
  • Children under 6 months of age: ask a doctor.
  • Reapply at least every 2 hours
  • Use 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 the 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-sleeved shirts, pants, hats, and sunglasses.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf (Aloe Vera Gel) Juice, Aqua (Deionized Water), Butyloctyl Salicylate, Calendula Officinalis Extract, Camellia Sinensis (Green Tea) Extract, Caprylic/Capric Triglyceride, Caprylyl Glycol, Citric Acid, Citrullus Lanatus (Watermelon) Extract, Cocos Nucifera (Coconut) Oil, Daucus Carota Sativa (Carrot) Extract, Glycerin, Glyceryl Laurate, Glyceryl Stearate, Glyceryl Stearate Citrate, Glyceryl Undecylenate, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Isododecane, Magnesium Aluminum Silicate, Polyhydroxystearic Acid, Polysorbate-20, Punica Granatum (Pomegranate) Extract, Teprenone, Tocopherol (Vitamin E), Tridecyl Salicylate, Trimethylsiloxysilicate.

Other information

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and direct sun.
  • May stain or damage some fabrics, materials or surfaces.

Questions or comments?

OTC - QUESTIONS SECTION

Call 216-245-8689

Package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label.jpgLabel.jpg

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
84259-475-00SUN CONTROL BROAD SPECTRUM SPF 30100 mL in 1 TUBECREAM1001
84259-475-00SUN CONTROL BROAD SPECTRUM SPF 301 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84259-475SUN CONTROL BROAD SPECTRUM SPF 30 (HOMOSALATE, OCTISALATE, ZINC OXIDE) CREAM [SKINPLAN.US LLC]1Current NDC, 2 package rows20240423_8e34a343-7253-469f-9973-076a7ae26cbc.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
84259-47584259-475-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 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
SUN CONTROL BROAD SPECTRUM SPF 30HOMOSALATE, OCTISALATE, ZINC OXIDESKINPLAN.US LLC8e34a343-7253-469f-9973-076a7ae26cbc2024-04-15WarningsExact identifier
ndc (package): 84259-475-00
ndc (product): 84259-475
ndc11 (package): 84259047500
spl id: 161fc0cf-491c-2123-e063-6294a90aaa7a
spl set id: 8e34a343-7253-469f-9973-076a7ae26cbc

Reported adverse events (FAERS/openFDA)#

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