NDC | 43219-300-12, 43219-300-30, 43219-300-40 |
Set ID | ffd6941e-ca63-499e-93ab-db327de793ca |
Category | HUMAN OTC DRUG LABEL |
Packager | Emilia Cosmetics Ltd |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
-
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 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
- STORAGE AND HANDLING
-
INACTIVE INGREDIENT
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
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
SUNZEE BROAD SPECTRUM SPF 40 SUNSCREEN
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:43219-300 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.56 g in 36 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 1.26 g in 36 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:43219-300-12 12 in 1 DOSE PACK 07/07/2017 1 NDC:43219-300-40 36 mL in 1 CAPSULE; Type 0: Not a Combination Product 2 NDC:43219-300-30 30 in 1 DOSE PACK 07/07/2017 2 NDC:43219-300-40 36 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 07/06/2017 Labeler - Emilia Cosmetics Ltd (600076624)