Red Gecko™

Red Gecko™
SPL v4
SPL
SPL Set ID 05bcce73-8ea2-499c-9752-d96b7c5707a0
Route
TOPICAL
Published
Effective Date 2021-07-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Zinc Cation (18 g)
Inactive Ingredients
Aloe Vera Leaf Alkyl (c12-15) Benzoate Medium-chain Triglycerides Glyceryl Monostearate Sunflower Oil Castor Oil Yellow Wax Rice Bran Sorbitan Sesquioleate Glycerin Cetyl Alcohol Stearyl Alcohol Magnesium Aluminum Silicate Shea Butter Camellia Sinensis Flower Ilex Paraguariensis Leaf Rosa Canina Fruit Oil .alpha.-tocopherol Acetate Safflower Oil Raspberry Squalane Xanthan Gum Propanediol Ethylhexylglycerin Potassium Sorbate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2020-07-02 Until 2026-04-30

Description

Zinc Oxide 18%

Purpose

Sunscreen


Medication Information

Purpose

Sunscreen

Description

Zinc Oxide 18%

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.

Section 42229-5

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

Section 50565-1

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

Warnings

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.

Packaging

Directions

• 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.

Drug Facts

Questions?

Call us! (702) 275-6167

Active Ingredient

Zinc Oxide 18%

Other Information

• Protect this product from excessive heat and direct sun.

Inactive Ingredients

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.


Structured Label Content

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.

Section 42229-5 (42229-5)

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

Section 50565-1 (50565-1)

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

Purpose

Sunscreen

Warnings

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.

Packaging

Directions

• 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.

Drug Facts

Questions?

Call us! (702) 275-6167

Active Ingredient (Active ingredient)

Zinc Oxide 18%

Other Information (Other information)

• Protect this product from excessive heat and direct sun.

Inactive Ingredients (Inactive ingredients)

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.


Advanced Ingredient Data


Raw Label Data

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