SUNZEE BROAD SPECTRUM SPF 40 SUNSCREEN- titanium dioxide, zinc oxide cream

SUNZEE by

Drug Labeling and Warnings

SUNZEE by is a Otc medication manufactured, distributed, or labeled by Emilia Cosmetics Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Titanium Dioxide, 7.1%

Zinc Oxide, 3.5%

PURPOSE

Purpose

Sunscreen

Sunscreen

INDICATIONS & USAGE

Uses

helps prevent sunburn

if used as directed with other sun protection

measures (see Directions), decreases the risk

of skin cancer and early skin aging caused by

the sun.

WARNINGS

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 a doctor if rash occurs

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical

help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

apply liberally 15 minutes before sun exposure

reapply at least every 2 hours

use water resistant sunscreen if swimming or sweating

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 sunglassses

STORAGE AND HANDLING

Other information protect the product in this

container from excessive heat and direct sun

INACTIVE INGREDIENT

Inactive Ingredients water, caprylic/capric

triglyceride, sesamum indicum (sesame) seed oil,

trimethoxycaprylylsilane, helianthus annuus (sunflower)

seed oil, glycerin, coco-glucoside, coconut alcohol, ricinus

communis (castor) oil, simmondsia chinensis (jojoba) seed

oil, butyrospermum parkii (shea) butter, microcrystalline

cellulose, cellulose gum, arachidyl alcohol, behenyl

alcohol, arachidyl glucoside, phenoxyethanol,

ethylhexylglycerin, xanthan gum, PEG-40 stearate,

fragrance, allantoin, tocopheryl acetate (viatmin E),

panthenol (pro-vitamin B5), lecithin, soy isoflavones,

polysorbate 80, alcohol denat., hippophae rhamnoides

oil, bisabolol

PRINCIPAL DISPLAY PANEL

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNZEE  BROAD SPECTRUM SPF 40 SUNSCREEN
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43219-300
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	2.56 g  in 36 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	1.26 g  in 36 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE (UNII: FJ1H6M2JG9)
SESAME OIL (UNII: QX10HYY4QV)
TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERIN (UNII: PDC6A3C0OX)
COCO GLUCOSIDE (UNII: ICS790225B)
COCONUT ALCOHOL (UNII: 13F4MW8Y9K)
CASTOR OIL (UNII: D5340Y2I9G)
JOJOBA OIL (UNII: 724GKU717M)
SHEA BUTTER (UNII: K49155WL9Y)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
ARACHIDYL GLUCOSIDE (UNII: 6JVW35JOOJ)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
XANTHAN GUM (UNII: TTV12P4NEE)
PEG-40 STEARATE (UNII: ECU18C66Q7)
ALLANTOIN (UNII: 344S277G0Z)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PANTOTHENIC ACID (UNII: 19F5HK2737)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)
SOY ISOFLAVONES (UNII: 71B37NR06D)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ALCOHOL (UNII: 3K9958V90M)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
LEVOMENOL (UNII: 24WE03BX2T)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43219-300-12	12 in 1 DOSE PACK	07/07/2017
1	NDC: 43219-300-40	36 mL in 1 CAPSULE; Type 0: Not a Combination Product
2	NDC: 43219-300-30	30 in 1 DOSE PACK	07/07/2017
2	NDC: 43219-300-40	36 mL in 1 CAPSULE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	07/06/2017

Labeler - Emilia Cosmetics Ltd (600076624)