FDA.reportPublic FDA data

RED GECKO BROAD SPECTRUM SPF 30 SUNSCREEN

Manufacturer
Formula 7venz L.L.C.
Effective date
2025-12-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:36:23

Label at a glance#

ProductRED GECKO BROAD SPECTRUM SPF 30 SUNSCREEN
Active ingredientZINC OXIDE
Label structure10 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 aging caused by the sun

Dosage and administration

• Apply liberally 15 minutes before sun exposure • Reapply: After 80 minutes of swimming and sweating · immediately after towel drying · at least every 2 hours • 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 tim...

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 14.6% w/w

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 aging caused by the sun

Warnings

WARNINGS SECTION

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 or irritation develops and lasts.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 and sweating · immediately after towel drying · at least every 2 hours

• 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 a.m. - 2 p.m. · Wear long sleeve shirts, pants, hats, & sunglasses

• Children under 6 months: Ask a doctor

Other information

STORAGE AND HANDLING SECTION

Protect this product from excessive heat and direct sun.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, Coco-Caprylate/Caprate, Isoamyl Laurate, Glycerin, Propanediol, Shea (Butyrospermum Parkii) Butter, Jojoba (Simmondsia Chinensis) Seed Oil, Polyglyceryl-6 Stearate, Polyglyceryl-6 Behenate, Aloe Barbadensis Leaf Extract, Green Tea (Camellia Sinensis) Leaf Extract, Sphingomonas Ferment Extract, Pongamia Pinnata Seed Extract, Xanthum Gum, Cetyl Alcohol, Silica, Lecithin, Sclerotium Gum, Polyhydroxystearic Acid, Triethoxycaprylylsilane, Pullulan, Phenoxyethanol, Ethylhexylglycerin

Questions?

OTC - QUESTIONS SECTION

(866) MAUITAN | (866) 628-4826

SPL UNCLASSIFIED SECTION

SHEER MINERAL

No White Cast

80 MINUTES WATER RESISTANCE

REEF COMPLIANT

Fragrance Free

Non Greasy

TSA Friendly

Distributed by:
Formula 7venz, LLC. Las Vegas Nevada
RND Department:
118 Kupuohi Street Suite C4, Lahaina, HI 96761
redgeckosunscreen.com

BORN ON MAUI
MADE IN USA

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

RED GECKO SUNSCREENRED GECKO SUNSCREEN

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130853832004094GTIN-13: 0853832004094
EAN-13: 0853832004094
GTIN-12: 853832004094
UPC-A: 853832004094
GTIN storage (14 digits): 00853832004094		82086004-3.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82086-004-76RED GECKO BROAD SPECTRUM SPF 30 SUNSCREEN85 g in 1 TUBECREAM851

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82086-00482086-004-76

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
ZINC OXIDESOI2LOH54ZACTIB
WATER059QF0KO0RIACT
COCOYL CAPRYLOCAPRATE8D9H4QU99HIACT
ISOAMYL LAURATEM1SLX00M3MIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
SHEA BUTTERK49155WL9YIACT
JOJOBA OIL724GKU717MIACT
POLYGLYCERYL-6 STEARATEETY9Q81E2TIACT
POLYGLYCERYL-6 BEHENATE4T2L7QI313IACT
ALOE VERA LEAFZY81Z83H0XIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
FERMENT COMPLEX 6/PFRH73PR9HMAIACT
PONGAMIA PINNATA SEEDC2BRV53B1VIACT
XANTHAN GUMTTV12P4NEEIACT
CETYL ALCOHOL936JST6JCNIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SOYBEAN LECITHIN1DI56QDM62IACT
BETASIZOFIRAN2X51AD1X3TIACT
POLYHYDROXYSTEARIC ACID (2300 MW)YXH47AOU0FIACT
TRIETHOXYCAPRYLYLSILANELDC331P08EIACT
PULLULAN8ZQ0AYU1TTIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT

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
RED GECKO BROAD SPECTRUM SPF 30 SUNSCREENZINC OXIDEFormula 7venz L.L.C.e8e350e7-9225-4802-89a6-66e45ebc442d2025-12-31WarningsExact identifier
ndc (package): 82086-004-76
ndc (product): 82086-004
ndc11 (package): 82086000476
spl id: a2162ea1-9760-4915-ac9a-f91a8db6ee63
spl set id: e8e350e7-9225-4802-89a6-66e45ebc442d

Reported adverse events (FAERS/openFDA)#

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