FDA.reportPublic FDA data

Red Gecko Broad Spectrum SPF 30 Sunscreen

Manufacturer
Formula 7venz L.L.C.
Effective date
2025-12-16
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
monthly-update
Hydrated at
2026-06-03 17:51:18

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 cancer and early skin aging caused by the sun.

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. 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 1...

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 18%

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 cancer and early skin 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 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.

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 10 a.m. - 2 p.m.

•  Wear long-sleeved shirts, pants, hats, and sunglasses.

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, helianthus annuus (sunflower) seed

oil, ricinus communis (castor) seed oil, beeswax, oryza sativa (rice) bran wax, sorbitan sesquioleate, glycerin, cetyl alcohol, stearyl

alcohol, magnesium aluminum silicate, butyrospermum parkii (shea) butter, camellia sinensis flower extract, ilex paraguariensis

leaf extract, rosa canina fruit oil, tocopheryl acetate, carthamus tinctorius (safflower) seed oil, rubus idaeus (raspberry) fruit

extract, squalane, xanthan gum, propanediol, ethylhexylglycerin, potassium sorbate.

Questions?

OTC - QUESTIONS SECTION

Call us! (702) 275-6167

SPL UNCLASSIFIED SECTION

REEF SAFE

NON-NANO

BORN ON MAUI

MADE IN USA

Save your skin 

Save our reefs

TSA Friendly

Fragrance Free

Distributed by: Formula 7venz, LLC.

118 Kupuohi Street Suite C-4

Lahaina, HI 96761

redgeckosunscreen.com

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PackagingPackaging

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

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
82086-00282086-002-34

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
SUNFLOWER OIL3W1JG795YIIACT
CASTOR OILD5340Y2I9GIACT
YELLOW WAX2ZA36H0S2VIACT
RICE BRANR60QEP13ICIACT
SORBITAN SESQUIOLEATE0W8RRI5W5AIACT
GLYCERINPDC6A3C0OXIACT
CETYL ALCOHOL936JST6JCNIACT
STEARYL ALCOHOL2KR89I4H1YIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
SHEA BUTTERK49155WL9YIACT
CAMELLIA SINENSIS FLOWER9I2BJY2J17IACT
ILEX PARAGUARIENSIS LEAF1Q953B4O4FIACT
ROSA CANINA FRUIT OILCR7307M3QZIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
SAFFLOWER OIL65UEH262ISIACT
RASPBERRY4N14V5R27WIACT
SQUALANEGW89575KF9IACT
XANTHAN GUMTTV12P4NEEIACT
PROPANEDIOL5965N8W85TIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
POTASSIUM SORBATE1VPU26JZZ4IACT

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
95e26c35-23d2-4a08-871f-ef7decd4866905bcce73-8ea2-499c-9752-d96b7c5707a02025-12-16WarningsExact identifier
spl id: 95e26c35-23d2-4a08-871f-ef7decd48669
spl set id: 05bcce73-8ea2-499c-9752-d96b7c5707a0

Reported adverse events (FAERS/openFDA)#

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