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

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.

----------

EMILIA NAKED SUN SPF 5 INVISIBLE FACE GEL

Active ingredients

Avobenzone, 3%

Homosalate, 15%

Octisalate, 5%

Octocrylene, 10%

Oxybenzone, 4%

Purpose

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 sunglasses.

Other information • protect the product in this container

from excessive heat and direct sun.

Inactive ingredients isohexadecane,

dimethicone/bis-isobutyl PPG-20

crosspolymer, cyclopentasiloxane,

fragrance, tocopherol acetate (vitamin E),

plukenetia volubilis seed oil, tocopherol,

bisabolol, astaxanthin.

emilia

Naked Sun

SPF 50 INVISIBLE FACE GEL   

BROAD SPECTRUM SPF50 SUNSCREEN

WATER RESISTANT (80 MINUTES)

image description

EMILIA  NAKED SUN SPF 50 INVISIBLE FACE GEL
avobenzone, homosalate, octisalate, octocrylene, oxybenzone gel
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42421-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX) AVOBENZONE1.5 g  in 50 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S) HOMOSALATE7.5 g  in 50 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE2.5 g  in 50 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE5 g  in 50 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE2 g  in 50 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42421-102-011 in 1 CARTON12/13/201709/30/2021
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 not finalpart35212/13/201709/30/2021
Labeler - Emilia Personal Care Inc (965445112)

Revised: 6/2023
 
Emilia Personal Care Inc