emilia by Emilia Cosmetics Ltd

emilia by

Drug Labeling and Warnings

emilia by is a Otc medication manufactured, distributed, or labeled by Emilia Cosmetics Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EMILIA BROAD SPECTRUM- octinoxate 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

Octinoxate, 4.0%

Purpose

Sunscreen

Uses

helps prevent sunburn

if used as directedwith 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 two 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 sunglasses

Other information protect the product in this

container from ecessive heat and direct sun

Inactive ingredients: water, titanium dioxide, potassium cetyl phosphate,

cyclopentasiloxane, talc, glyceryl myristate, butylene glycol,

propandiol, behenyl alcohol, C12-15 alkyl benzoate,

caprylic/capric triglyceride, isohexadecane, isononyl isononanoate,

boron nitride, microcrystalline cellulose, cellulose gum, glycerin, sodium lactate,

lactic acid, TEA-lactate, serine, urea, sorbitol, sodium chloride, allantoin,

phenoxyethanol, ethylhexylglycerin, nylon-12, iron oxides, ammonium

acryloyldimethyltaurate/

VP copolymer, fragrance, triethanolamine,

caffeine, disodium EDTA, tocopheryl acetate (vitamin E), opuntia streptacantha

stem extract, lepidium sativum sprout extract, lecithin, hyaluronic acid

image description

EMILIA  BROAD SPECTRUM
octinoxate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 43219-004
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE2 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POTASSIUM CETYL PHOSPHATE (UNII: 03KCY6P7UT)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
TALC (UNII: 7SEV7J4R1U)  
GLYCERYL MYRISTATE (UNII: 6992Y81827)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
PROPANEDIOL (UNII: 5965N8W85T)  
DOCOSANOL (UNII: 9G1OE216XY)  
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
ISOHEXADECANE (UNII: 918X1OUF1E)  
ISONONYL ISONONANOATE (UNII: S4V5BS6GCX)  
BORON NITRIDE (UNII: 2U4T60A6YD)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
LACTIC ACID (UNII: 33X04XA5AT)  
TRIETHANOLAMINE LACTATE (UNII: 064C51N81O)  
SERINE (UNII: 452VLY9402)  
UREA (UNII: 8W8T17847W)  
SORBITOL (UNII: 506T60A25R)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
ALLANTOIN (UNII: 344S277G0Z)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
NYLON-12 (UNII: 446U8J075B)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI)  
COPOVIDONE K25-31 (UNII: D9C330MD8B)  
TROLAMINE (UNII: 9O3K93S3TK)  
CAFFEINE (UNII: 3G6A5W338E)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
OPUNTIA STREPTACANTHA STEM (UNII: 3TF9Z1U73O)  
GARDEN CRESS SPROUT (UNII: PWQ18YNR62)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
HYALURONIC ACID (UNII: S270N0TRQY)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 43219-004-151 in 1 CARTON10/01/201708/23/2019
150 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35210/01/201708/23/2019
Labeler - Emilia Cosmetics Ltd (600076624)

Revised: 2/2020
 
Emilia Cosmetics Ltd