SUNZEE FACE AND NECK SUNSCREEN- titanium dioxide, zinc oxide cream
Emilia Cosmetics Ltd

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Active ingredients

Titanium Dioxide, 7.6%

Zinc Oxide, 3.5%

Purpose

Sunscreen

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

• 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. If swallowed, get

medical help or contact a Poison Control Center

right away.

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

Other information protect the product in this

container from excessive heat and direct sun

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

image description

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

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP)	TITANIUM DIOXIDE	0.076 g in 81 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC CATION	0.035 g in 81 mL

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date
Packaging
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 Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	12/30/2017	12/30/2017

Labeler - Emilia Cosmetics Ltd (600076624)

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

Revised: 8/2020

Document Id: ada4622f-898a-1f6f-e053-2995a90a70b7

Set id: fa419ee9-0b43-4b6d-b77f-c8d7c6dadec0

Version: 2

Effective Time: 20200824

Emilia Cosmetics Ltd