Sun Bum Signature Lotion Clear SPF 50

Manufacturer
Sun Bum LLC
Effective date
2022-02-04
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:48:03

Label at a glance#

ProductSun Bum Signature Clear SPF 50
Active ingredientOCTISALATE, OCTOCRYLENE, ZINC OXIDE
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

shake well before use apply liberally 15 minutes before sun exposure reapply: after 80 minutes of swimming or sweating immediately after towel drying at least every 2 hours children under 6 months of age:ask a doctor 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 hig...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Octisalate 5%, Octocrylene 10%. Zinc oxide 10%

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • shake well before use
  • apply liberally 15 minutes before sun exposure
  • reapply:
  • after 80 minutes of swimming or sweating
  • immediately after towel drying
  • at least every 2 hours
  • children under 6 months of age:ask a doctor
  • 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 10a.m. - 2.p.m.
  • wear long-sleeve shirts, pants, hats, and sunglasses.

Other information

SPL UNCLASSIFIED SECTION

  • protect this product from excessive heat and direct sun. Keep outer carton for complete labeling information

Inactive ingredients

INACTIVE INGREDIENT SECTION

water, C12-15 alkyl benzoate, triethylpentanediol/ adipic acid copolymer, butyrospermum parkii (shee) butter, glycerin, polyster-8, arachidyl alcohol, panthenol, aloe barbadensis leaf juice, tocopheryl acetate, sodium hyaluronate, ascorbyl palmitate, beeswax, behenylalcohol, arachidyl glucoside, sorbitan oleate, sorbitol, lecithin, xanthan gum, oleic acid, glyceryl caprylate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, triethoxycaprylylate, disodium EDTA, phenoxyethanol, caprylyl glycol, ethylhexylglycerin

Questions?

OTC - QUESTIONS SECTION

1(877)978-6286

Package Labeling:44ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

BottleBottleBottle2Bottle2

Package Labeling:88ml

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle3Bottle3Bottle4Bottle4

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69039-617-01Sun Bum Signature Clear SPF 5044 mL in 1 BOTTLELOTION443
69039-617-02Sun Bum Signature Clear SPF 5088 mL in 1 BOTTLELOTION883

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69039-617SUN BUM SIGNATURE CLEAR SPF 50 (OCTISALATE, OCTOCRYLENE, ZINC OXIDE) LOTION [SUN BUM LLC]3Legacy NDC, 2 package rows20220205_b5f52185-aed4-3fc8-e053-2995a90a3332.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
69039-61769039-617-01, 69039-617-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 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
d73c8765-0e86-fde2-e053-2995a90ae4c2b5f52185-aed4-3fc8-e053-2995a90a33322022-02-04WarningsExact identifier
spl id: d73c8765-0e86-fde2-e053-2995a90ae4c2
spl set id: b5f52185-aed4-3fc8-e053-2995a90a3332

Reported adverse events (FAERS/openFDA)#

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