SUNZEE FACE AND NECK 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, 7.6%

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 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 the 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

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, trimethoxycaprylylsilane, sesamum

indicum (sesame) seed oil, helianthus annuus

(sunflower) seed oil, glycerin, triethoxycaprylylsilane,

coco-glucoside, coconut alcohol, ricinus communis

(castor) oil, simmonsia 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 (vitamin E),

panthenol (pro-vitamin B5), lecithin, soy

isoflavones, polysorbate 80, hippophae rhamnoides

oil, bisabolol, carnosine, chamomilla recutita

(matricaria) flower, tilia vulgaris (linden blossom)

flower extract, melissa officinalis leaf extract,

aspalathus linearis(rooibos) leaf extract, sodium

lactate, porphyra umbilicalis extract

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SUNZEE  FACE AND NECK SUNSCREEN
titanium dioxide, zinc oxide cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43219-042
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	.076 g  in 81 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	.035 g  in 81 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
TRIMETHOXYCAPRYLYLSILANE (UNII: FZ07E4LW2M)
SESAME OIL (UNII: QX10HYY4QV)
SUNFLOWER OIL (UNII: 3W1JG795YI)
GLYCERIN (UNII: PDC6A3C0OX)
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)
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 ALCOHOL (UNII: 1QR1QRA9BU)
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)
HIPPOPHAE RHAMNOIDES SEED OIL (UNII: T53SBG6741)
LEVOMENOL (UNII: 24WE03BX2T)
CARNOSINE (UNII: 8HO6PVN24W)
MATRICARIA CHAMOMILLA (UNII: G0R4UBI2ZZ)
TILIA X EUROPAEA FLOWER (UNII: NHV2K1OUDH)
MELISSA OFFICINALIS LEAF (UNII: 50D2ZE9219)
ASPALATHUS LINEARIS LEAF (UNII: H7UGK1GJCU)
SODIUM LACTATE (UNII: TU7HW0W0QT)
PORPHYRA UMBILICALIS (UNII: 14AN0J70WO)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43219-042-30	30 in 1 CONTAINER	01/18/2018
1		81 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	01/18/2018

Labeler - Emilia Cosmetics Ltd (600076624)

Establishment
Name	Address	ID/FEI	Business Operations
Emilia Cosmetics Ltd		600076624	manufacture(43219-042)