AURELI BROAD SPECTRUM- avobenzone, homosalate, octisalate, octocrylene, oxybenzone gel
Emilia Personal Care

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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Drug Facts

Active ingredients

Avobenzone, 3.0%

Homosalate, 10.0%

Octisalate, 5.0%

Octocrylene, 2.0%

Oxybenzone, 4.0%

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 - isododecane,

dimethicone/bis-isobutyl PPG-20 crosspolymer,

dicaprylyl ether, mica, titanium dioxide, silica, iron

oxides, tin oxide, fragrance, tocopheryl acetate

(vitamin E), plukenetia volubilis seed oil,

tocopherol, astaxanthin

AURELI BROAD SPECTRUM
avobenzone, homosalate, octisalate, octocrylene, oxybenzone gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42421-192
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	3 g in 100 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	10 g in 100 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5 g in 100 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	2 g in 100 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
ISODODECANE (UNII: A8289P68Y2)
DIMETHICONE/BIS-ISOBUTYL PPG-20 CROSSPOLYMER (UNII: O4I3UFO6ZF)
DIDECYL ETHER (UNII: DA81HI310Z)
MICA (UNII: V8A1AW0880)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FERRIC OXIDE RED (UNII: 1K09F3G675)
STANNIC OXIDE (UNII: KM7N50LOS6)
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)
PLUKENETIA VOLUBILIS SEED OIL (UNII: 8ED72Z8J1Z)
TOCOPHEROL (UNII: R0ZB2556P8)
ASTAXANTHIN (UNII: 8XPW32PR7I)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:42421-192-15	1 in 1 CARTON	03/01/2015	12/31/2018
1		50 mL in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part352	03/01/2015	12/31/2018

Labeler - Emilia Personal Care (965445112)

Revised: 12/2018

Document Id: 7e184d40-baa4-42a2-e053-2a91aa0acdc8

Set id: caba0b1b-351c-4598-bf49-dfb85f055cae

Version: 4

Effective Time: 20181228

Emilia Personal Care