EMILIA NAKED SUN SPF 50 INVISIBLE FACE GEL- avobenzone, homosalate, octisalate, octocrylene, oxybenzone gel

emilia by

Drug Labeling and Warnings

emilia by is a Otc medication manufactured, distributed, or labeled by Emilia Personal Care Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active ingredients

Avobenzone, 3%

Homosalate, 15%

Octisalate, 5%

Octocrylene, 10%

Oxybenzone, 4%

PURPOSE

Purpose

Sunscreen

INDICATIONS & USAGE

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

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

Keep out of reach of children. If swallowed, get medical

help or contact a Poison Control Center right away.

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 sunglasses.

STORAGE AND HANDLING

Other information protect the product in this container

from excessive heat and direct sun.

INACTIVE INGREDIENT

Inactive ingredients isohexadecane,

dimethicone/bis-isobutyl PPG-20

crosspolymer, cyclopentasiloxane,

fragrance, tocopherol acetate (vitamin E),

plukenetia volubilis seed oil, tocopherol,

bisabolol, astaxanthin.

PRINCIPAL DISPLAY PANEL

emilia

Naked Sun

SPF 50 INVISIBLE FACE GEL   

BROAD SPECTRUM SPF50 SUNSCREEN

WATER RESISTANT (80 MINUTES)

INGREDIENTS AND APPEARANCE

EMILIA  NAKED SUN SPF 50 INVISIBLE FACE GEL
avobenzone, homosalate, octisalate, octocrylene, oxybenzone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42421-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	1.5 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	7.5 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	2.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	5 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	2 g  in 50 mL

Inactive Ingredients
Ingredient Name	Strength
ISOHEXADECANE (UNII: 918X1OUF1E)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
PLUKENETIA VOLUBILIS SEED OIL (UNII: 8ED72Z8J1Z)
TOCOPHEROL (UNII: R0ZB2556P8)
LEVOMENOL (UNII: 24WE03BX2T)
ASTAXANTHIN (UNII: 8XPW32PR7I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42421-102-01	1 in 1 CARTON	12/13/2017
1		50 mL in 1 TUBE; 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	12/13/2017

Labeler - Emilia Personal Care Inc (965445112)