MAUI ISLAND SECRET BROWNING CREME BROAD SPECTRUM SPF 5 SUNSCREEN- zinc oxide cream

Maui Island Secret Browning Creme Broad Spectrum SPF 5 Sunscreen by

Drug Labeling and Warnings

Maui Island Secret Browning Creme Broad Spectrum SPF 5 Sunscreen by is a Otc medication manufactured, distributed, or labeled by Formula 7venz L.L.C.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Zinc Oxide 7%

Purpose

Sunscreen

Uses

  Helps prevent sunburn.

Warnings

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.

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.

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, 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?

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

INGREDIENTS AND APPEARANCE

MAUI ISLAND SECRET BROWNING CREME BROAD SPECTRUM SPF 5 SUNSCREEN 
zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 82086-001
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	7 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
ALOE VERA LEAF (UNII: ZY81Z83H0X)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
YELLOW WAX (UNII: 2ZA36H0S2V)
SUNFLOWER OIL (UNII: 3W1JG795YI)
CASTOR OIL (UNII: D5340Y2I9G)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)
CETYL ALCOHOL (UNII: 936JST6JCN)
STEARYL ALCOHOL (UNII: 2KR89I4H1Y)
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)
ARABICA COFFEE OIL (UNII: IK55HKE887)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ILEX PARAGUARIENSIS LEAF (UNII: 1Q953B4O4F)
ROSA CANINA FRUIT OIL (UNII: CR7307M3QZ)
SAFFLOWER OIL (UNII: 65UEH262IS)
RASPBERRY (UNII: 4N14V5R27W)
SQUALANE (UNII: GW89575KF9)
MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)
XANTHAN GUM (UNII: TTV12P4NEE)
PROPANEDIOL (UNII: 5965N8W85T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
CARAMEL (UNII: T9D99G2B1R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 82086-001-08	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/02/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/02/2020

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