FDA.reportPublic FDA data

SPF 50 Signature High Performance Sunscreen

Manufacturer
Sun Bum LLC
Effective date
2019-05-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 00:23:48

Label at a glance#

ProductSPF 50 Signature High Performance Sunscreen
Active ingredientOCTINOXATE, OCTISALATE, OCTOCRYLENE, ZINC OXIDE
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. Children under 6 months: 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 Broad Spectrum SPF of 15 or higher and other sun protection mea...

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Octinoxate 7.5%, Octisalate 5%, Octocrylene 7%, 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 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.
  • Children under 6 months: 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 Broad Spectrum SPF of 15 or higher and other sun protection measures, including:
  • Limit time in the sun, especially from 10 am - 2 pm.
  • Wear long-sleeved shirts, pants, hats, and sunglasses.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

water, C12-15 alkyl benzoate, trimethylpentanediol/adipic acid copolymer, arachidyl alcohol, butyrospermum parkii (shea) butter, glycerin, polyester-8, aloe barbadensis leaf juice, tocopheryl acetate, sorbitol, beeswax, xanthan gum, lecithin, oleic Acid, caprylyl glycol, disodium EDTA, glyceryl caprylate, phenoxyethanol, sorbitan oleate, hydroxyethyl acrylate/sodium acryloyldimethyl taurate, panthenol, ethylhexylglycerin, sodium hyaluronate, ascorbyl palmitate, behenyl alcohol, arachidyl glucoside, methylisothiazolinone, CI 77491

Other Information

SPL UNCLASSIFIED SECTION

  • Protect this product from excessive heat and directed sun.

Questions?

OTC - QUESTIONS SECTION

Call 1-877-978-6286

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69039-228-012022-02-06C16284748780-1d6a99b39-503b-a426-e053-dadaa90af4c2SPF 50 Signature High Performance Sunscreen
69039-228-012022-01-28C16284748780-1d6a99b39-503b-a426-e053-dadaa90af4c2SPF 50 Signature High Performance Sunscreen

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69039-22869039-228-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
ARACHIDYL ALCOHOL1QR1QRA9BUIACT
SHEA BUTTERK49155WL9YIACT
GLYCERINPDC6A3C0OXIACT
POLYESTER-8 (1400 MW, CYANODIPHENYLPROPENOYL CAPPED)T9296U138PIACT
SORBITOL506T60A25RIACT
YELLOW WAX2ZA36H0S2VIACT
XANTHAN GUMTTV12P4NEEIACT
OLEIC ACID2UMI9U37CPIACT
CAPRYLYL GLYCOL00YIU5438UIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
GLYCERYL MONOCAPRYLATETM2TZD4G4AIACT
PHENOXYETHANOLHIE492ZZ3TIACT
SORBITAN MONOOLEATE06XEA2VD56IACT
HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%)86FQE96TZ4IACT
PANTHENOLWV9CM0O67ZIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
HYALURONATE SODIUMYSE9PPT4THIACT
ASCORBYL PALMITATEQN83US2B0NIACT
DOCOSANOL9G1OE216XYIACT
ARACHIDYL GLUCOSIDE6JVW35JOOJIACT
METHYLISOTHIAZOLINONE229D0E1QFAIACT
ALOE VERA LEAFZY81Z83H0XIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
FERRIC OXIDE RED1K09F3G675IACT
OCTINOXATE4Y5P7MUD51ACTIB
OCTISALATE4X49Y0596WACTIB
OCTOCRYLENE5A68WGF6WMACTIB
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
d76412aa-897e-d5ac-e053-2a95a90ab7eb896b26b6-a35b-5df7-e053-2995a90adc1a2022-02-06WarningsExact identifier
spl set id: 896b26b6-a35b-5df7-e053-2995a90adc1a

Reported adverse events (FAERS/openFDA)#

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