RED GECKO BROAD SPECTRUM SPF 30 SUNSCREEN- zinc oxide lotion

Drug Details [pdf]

Drug Facts
Active ingredient

Zinc Oxide 18%
Purpose

Sunscreen
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.
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.

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

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

INGREDIENTS AND APPEARANCE

RED GECKO BROAD SPECTRUM SPF 30 SUNSCREEN
zinc oxide lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82086-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	18 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CASTOR OIL (UNII: D5340Y2I9G)
YELLOW WAX (UNII: 2ZA36H0S2V)
RICE BRAN (UNII: R60QEP13IC)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
GLYCERIN (UNII: PDC6A3C0OX)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
SHEA BUTTER (UNII: K49155WL9Y)
CAMELLIA SINENSIS FLOWER (UNII: 9I2BJY2J17)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
SAFFLOWER OIL (UNII: 65UEH262IS)
RASPBERRY (UNII: 4N14V5R27W)
SQUALANE (UNII: GW89575KF9)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPANEDIOL (UNII: 5965N8W85T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 82086-002-34	100 mL in 1 TUBE; Type 0: Not a Combination Product	07/02/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	07/02/2020

Labeler - Formula 7venz L.L.C. (118069729)

RED GECKO BROAD SPECTRUM SPF 30 SUNSCREEN- zinc oxide lotion

Red Gecko Broad Spectrum SPF 30 Sunscreen by

Drug Labeling and Warnings

Drug Details [pdf]