FDA.reportPublic FDA data

Broad Spectrum SPF 35 ECO

Manufacturer
Allure Labs Inc | Allure Labs Inc.
Effective date
2021-01-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:57:34

Label at a glance#

ProductBroad Spectrum SPF 35 ECO
Active ingredientZINC OXIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient:

Zinc Oxide - 18.9%

OTC - PURPOSE SECTION

Purpose: Sunscreen

WARNINGS SECTION

Warnings: For external use only.

OTC - WHEN USING SECTION

When using this product:

  • Keep out of eyes. Rinse with water to remove.
  • Stop and ask a doctor if rash or irritation occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

Directions:

Apply liberally 15 minutes before sun exposure.
Reapply: after swimming or sweating. Immediately after towel drying. At least every 2 hours.

OTC - ASK DOCTOR SECTION

Children under 6 months: Ask a doctor.

INACTIVE INGREDIENT SECTION

Inactive Ingrediaents: Caprylic/Capric Triglyceride, Water (Aqua), Glycerin, Polysorbate 60, Stearic Acid, Cetyl Alcohol, Sorbitan Stearate, Cetearyl Glucoside, Stearyl Alcohol, Polyhydroxystearic Acid, Polyglyceryl-3 Ricinoleate, Isostearic Acid, Lecithin, Xanthan Gum, Carageenan, Helionori, Aloe Barbadensis Leaf Juice, Ascorbyl Palmitate, Tocopherol, Ethylhexylglycerin.

OTHER SAFETY INFORMATION

High sun protection product.

OTC - QUESTIONS SECTION

Call toll free 1-800-798-7970

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sun Research LLC

Santa Cruz, CA

www.burnoutsun.com

Image Broad Spectrum SPF 35 ECOImage Broad Spectrum SPF 35 ECO

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62742-411562742-4115-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
POLYHYDROXYSTEARIC ACID STEARATE8KQ7I65XZEIACT
ASCORBYL PALMITATEQN83US2B0NIACT
ISOSTEARIC ACIDX33R8U0062IACT
LECITHIN, SOYBEAN1DI56QDM62IACT
ALOE VERA LEAFZY81Z83H0XIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
STEARYL ALCOHOL2KR89I4H1YIACT
ZINC OXIDESOI2LOH54ZACTIB
GLYCERINPDC6A3C0OXIACT
POLYSORBATE 60CAL22UVI4MIACT
SORBITAN MONOSTEARATENVZ4I0H58XIACT
CETEARYL GLUCOSIDE09FUA47KNAIACT
TOCOPHEROLR0ZB2556P8IACT
CARRAGEENAN5C69YCD2YJIACT
PORPHYRA UMBILICALIS14AN0J70WOIACT
POLYGLYCERYL-3 RICINOLEATEMZQ63P0N0WIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
STEARIC ACID4ELV7Z65APIACT
CETYL ALCOHOL936JST6JCNIACT
XANTHAN GUMTTV12P4NEEIACT

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
b86e82bf-7c85-6fbe-e053-2995a90ae1a3b86e82bf-7c84-6fbe-e053-2995a90ae1a32021-01-08WarningsExact identifier
spl id: b86e82bf-7c85-6fbe-e053-2995a90ae1a3
spl set id: b86e82bf-7c84-6fbe-e053-2995a90ae1a3

Reported adverse events (FAERS/openFDA)#

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