FDA.reportPublic FDA data

Maui Island Secret Browning Creme Broad Spectrum SPF 5 Sunscreen

Manufacturer
Formula 7venz L.L.C.
Effective date
2024-12-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:45:49

Label at a glance#

ProductMaui Island Secret Browning Creme Broad Spectrum SPF 5 Sunscreen
Active ingredientZINC OXIDE
Label structure10 sections

Indications and uses

•  Helps prevent sunburn.

Dosage and administration

•  Apply liberally and evenly 15 minutes prior to sun exposure •  Reapply: After 40 minutes of swimming or sweating · immediately after towel drying · at least every 2 hours •  Children under 6 months of age: Ask a doctor.

Storage and handling

•  Protect this product from excessive heat and direct sun.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Zinc Oxide 7%

Purpose

OTC - PURPOSE SECTION

Sunscreen

Uses

INDICATIONS & USAGE SECTION

•  Helps prevent sunburn.

Warnings

WARNINGS SECTION

Skin cancer/skin aging alert: Spending time in the sun increases your risk of skin cancer and early skin aging. This product has been shown

only to prevent sunburn, not skin cancer or early skin aging.

For external use only

Do not use on damaged, or broken skin.

When using this product keep out of eyes. Rinse with water to remove.

Stop use and ask doctor if rash occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

•  Apply liberally and evenly 15 minutes prior to sun exposure

•  Reapply: After 40 minutes of swimming or sweating · immediately after towel drying · at least every 2 hours

•  Children under 6 months of age: Ask a doctor.

Other information

STORAGE AND HANDLING SECTION

•  Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, C12-15 alkyl benzoate, caprylic/capric triglyceride, glyceryl stearate, beeswax, helianthus annuus (sunflower) seed

oil, ricinus communis (castor) seed oil, glycerin, sorbitan sesquioleate, cetyl alcohol, stearyl alcohol, polyhydroxystearic acid, coffea arabica

(coffee) seed oil, camellia sinensis leaf extract, ilex paraguariensis leaf extract, rosa canina fruit oil, carthamus tinctorius (safflower) seed oil,

rubus idaeus (raspberry) fruit extract, squalane, magnesium aluminum silicate, xanthan gum, propanediol, ethylhexylglycerin, potassium sorbate,

fragrance, caramel.

Questions?

OTC - QUESTIONS SECTION

Call us! (702) 275-6167

SPL UNCLASSIFIED SECTION

The Original

Made with Aloe, Coffee Seed Oil, Rose Hips and Green Tea.

• Reef Safe • Never Tested on Animals •

Distributed by: Formula 7venz, LLC.

118 Kupuohi Street Suite C-4

Lahaina, HI 96761

www.MauiIslandSecret.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82086-001MAUI ISLAND SECRET BROWNING CREME BROAD SPECTRUM SPF 5 SUNSCREEN (ZINC OXIDE) CREAM [FORMULA 7VENZ L.L.C.]3Legacy NDC20241217_19b24ee3-6a28-443d-ae3d-e5e22e67ef85.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82086-00182086-001-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIM
ALOE VERA LEAFZY81Z83H0XIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
YELLOW WAX2ZA36H0S2VIACT
SUNFLOWER OIL3W1JG795YIIACT
CASTOR OILD5340Y2I9GIACT
GLYCERINPDC6A3C0OXIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
CETYL ALCOHOL936JST6JCNIACT
STEARYL ALCOHOL2KR89I4H1YIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
ARABICA COFFEE OILIK55HKE887IACT
GREEN TEA LEAFW2ZU1RY8B0IACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
SAFFLOWER OIL65UEH262ISIACT
RASPBERRY4N14V5R27WIACT
SQUALANEGW89575KF9IACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
XANTHAN GUMTTV12P4NEEIACT
PROPANEDIOL5965N8W85TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
CARAMELT9D99G2B1RIACT

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
2f43122b-3656-4078-aeed-96e0f591610e19b24ee3-6a28-443d-ae3d-e5e22e67ef852025-12-12WarningsExact identifier
spl set id: 19b24ee3-6a28-443d-ae3d-e5e22e67ef85

Reported adverse events (FAERS/openFDA)#

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