OTC Medication Information: Sunzee Face and Neck Sunscreen

SUNZEE FACE AND NECK SUNSCREEN- titanium dioxide and 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.

Active ingredients

Titanium Dioxide, 7.6%

Zinc Oxide, 3.5%

Purpose

Sunscreen

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
(click image for full-size original)

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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE .076 g in 81 mL
ZINC OXIDE (ZINC CATION) ZINC CATION .035 g in 81 mL
Inactive Ingredients
Ingredient Name Strength
WATER
MEDIUM-CHAIN TRIGLYCERIDES
TRIMETHOXYCAPRYLYLSILANE
SESAME OIL
SUNFLOWER OIL
GLYCERIN
TRIETHOXYCAPRYLYLSILANE
COCO GLUCOSIDE
COCONUT ALCOHOL
CASTOR OIL
JOJOBA OIL
SHEA BUTTER
MICROCRYSTALLINE CELLULOSE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
ARACHIDYL ALCOHOL
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
XANTHAN GUM
PEG-40 STEARATE
ALLANTOIN
.ALPHA.-TOCOPHEROL ACETATE
PANTOTHENIC ACID
LECITHIN, SOYBEAN
SOY ISOFLAVONES
POLYSORBATE 80
HIPPOPHAE RHAMNOIDES SEED OIL
LEVOMENOL
CARNOSINE
MATRICARIA CHAMOMILLA
TILIA X EUROPAEA FLOWER
MELISSA OFFICINALIS LEAF
ASPALATHUS LINEARIS LEAF
SODIUM LACTATE
PORPHYRA UMBILICALIS
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43219-042-30 30 CAPSULE in 1 CONTAINER contains a CAPSULE
1 81 mL in 1 CAPSULE This package is contained within the CONTAINER (43219-042-30)
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 Operations
Emilia Cosmetics Ltd 600076624 manufacture (43219-042)

Revised: 01/2018 Emilia Cosmetics Ltd

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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