SUNZEE BROAD SPECTRUM SPF 40 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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SUNZEE Broad Spectrum SPF 40 Sunscreen

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

image description

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SUNZEE  BROAD SPECTRUM SPF 40 SUNSCREEN
titanium dioxide, zinc oxide cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43219-300
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE2.56 g  in 36 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE1.26 g  in 36 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:43219-300-1212 in 1 DOSE PACK07/07/201712/31/2018
1NDC:43219-300-4036 mL in 1 CAPSULE; Type 0: Not a Combination Product
2NDC:43219-300-3030 in 1 DOSE PACK07/07/201712/31/2018
2NDC:43219-300-4036 mL in 1 CAPSULE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35207/06/201712/31/2018
Labeler - Emilia Cosmetics Ltd (600076624)

Revised: 6/2023
 
Emilia Cosmetics Ltd