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NDC 82086-0001-08 Maui Island Secret Browning Creme Broad Spectrum SPF 5 Sunscreen 7 g/100mL Details

Maui Island Secret Browning Creme Broad Spectrum SPF 5 Sunscreen 7 g/100mL

Maui Island Secret Browning Creme Broad Spectrum SPF 5 Sunscreen is a TOPICAL CREAM in the HUMAN OTC DRUG category. It is labeled and distributed by Formula 7venz L.L.C.. The primary component is ZINC OXIDE.

Product Information

NDC	82086-0001
Product ID	82086-001_147469bd-eecd-4de2-bb21-c0adae376f9e
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Maui Island Secret Browning Creme Broad Spectrum SPF 5 Sunscreen
Proprietary Name Suffix	n/a
Non-Proprietary Name	Zinc Oxide
Product Type	HUMAN OTC DRUG
Dosage Form	CREAM
Route	TOPICAL
Active Ingredient Strength	7
Active Ingredient Units	g/100mL
Substance Name	ZINC OXIDE
Labeler Name	Formula 7venz L.L.C.
Pharmaceutical Class	Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH NOT FINAL
Application Number	part352
Listing Certified Through	2024-12-31

Package

Package Images

NDC 82086-0001-08 (82086000108)

Pricing Information	N/A
NDC Package Code	82086-001-08
Billing NDC	82086000108
Package	236 mL in 1 BOTTLE (82086-001-08)
Marketing Start Date	2020-07-02
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 19b24ee3-6a28-443d-ae3d-e5e22e67ef85 Details

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

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:82086-001-08	236 mL in 1 BOTTLE; 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 not final	part352	07/02/2020

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

Revised: 7/2021

Document Id: 147469bd-eecd-4de2-bb21-c0adae376f9e

Set id: 19b24ee3-6a28-443d-ae3d-e5e22e67ef85

Version: 1

Effective Time: 20210705