OTC Medication Information: SUNZEE Broad Spectrum SPF 40 Sunscreen

SUNZEE BROAD SPECTRUM SPF 40 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, 7.1%

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 and 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 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

Other information protect the product in this

container from excessive heat and direct sun

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

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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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
TITANIUM DIOXIDE (TITANIUM DIOXIDE) TITANIUM DIOXIDE 2.56 g in 36 mL
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 1.26 g in 36 mL
Inactive Ingredients
Ingredient Name Strength
WATER
CAPRYLIC/CAPRIC/LAURIC TRIGLYCERIDE
SESAME OIL
TRIMETHOXYCAPRYLYLSILANE
SUNFLOWER OIL
GLYCERIN
COCO GLUCOSIDE
COCONUT ALCOHOL
CASTOR OIL
JOJOBA OIL
SHEA BUTTER
MICROCRYSTALLINE CELLULOSE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
ARACHIDYL GLUCOSIDE
PHENOXYETHANOL
ETHYLHEXYLGLYCERIN
XANTHAN GUM
PEG-40 STEARATE
ALLANTOIN
.ALPHA.-TOCOPHEROL ACETATE
PANTOTHENIC ACID
LECITHIN, SOYBEAN
SOY ISOFLAVONES
POLYSORBATE 80
ALCOHOL
HIPPOPHAE RHAMNOIDES SEED OIL
LEVOMENOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43219-300-12 12 CAPSULE30 CAPSULE in 1 DOSE PACK contains a CAPSULE (43219-300-40)
1 NDC:43219-300-30 12 CAPSULE30 CAPSULE in 1 DOSE PACK contains a CAPSULE (43219-300-40)
1 NDC:43219-300-40 36 mL in 1 CAPSULE This package is contained within a DOSE PACK (43219-300-12) and a DOSE PACK (43219-300-30)
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)

Revised: 07/2017 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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