EAD- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Avobenzone 2.0%, Homosalate 12.0%, Octisalate 5.0%, Octocrylene 2.0%, Oxybenzone 2.0%
Available from:
European Perfume Works Co. L.L.C
Administration route:
TOPICAL
Prescription type:
OTC DRUG
Therapeutic indications:
Sunscreen - 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.
Authorization status:
OTC monograph not final
Authorization number:
63049-103-23, 63049-103-25

EAD- avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

European Perfume Works Co. L.L.C

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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EAD

Active Ingredients

Avobenzone 2.0%

Homosalate 12.0%

Octisalate 5.0%

Octocrylene 2.0%

Oxybenzone 2.0%

Purpose

Sunscreen

Keep out of reach of children.

If product is swallowed, get medical help or contact a Poison Control Center right away.

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.

Directions

apply liberally 15 minutes before sun exposure

reapply

- after 80 minutes of swimming or sweating

- immediately after towel drying

- at least every 2 hours

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 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-sleeve shirts, pants, hats, and sunglasses

children under 6 months: Ask a doctor

Inactive Ingredients

amyl cinnamal, ascorbyl palmitate, benzyl alcohol, butylparaben, C12-15 alkyl benzoate,

carbomer, ceteareth-20, cetearyl alcohol, ethylparaben, fragrance, glyceryl stearate, glyceryl

stearate SE, isobutylparaben, linalool, methylparaben, PEG-100 stearate, phenoxyethanol,

propylene glycol, propylparaben, sodium hydroxide, sodium cetearyl sulfate, tetrasodium

EDTA, tocopheryl acetate, water.

Other Information

protect this product from excessive heat and direct sun.

Questions or Comments?

Call toll free 1-844-875-4176 (Mon-Fri 9AM-5PM CST)

USA Distributor

ARION PERFUME & BEAUTY INC,

SAN ANTONIO, TX - 78212

U.S.A.

Manufactured BY

EUROPEAN PERFUME WORKS CO.LLC

P.O Box 23121, Sharjah, United Arab Emirates

Packaging

EAD

avobenzone, homosalate, octisalate, octocrylene, oxybenzone lotion

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 30 49 -10 3

Route of Administration

TOPICAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

AVO BENZO NE (UNII: G6 3QQF2NOX) (AVOBENZONE - UNII:G6 3QQF2NOX)

AVOBENZONE

2.40 g in 120 mL

HO MO SALATE (UNII: V0 6 SV4M9 5S) (HOMOSALATE - UNII:V0 6 SV4M9 5S)

HOMOSALATE

14.40 g in 120 mL

O CTISALATE (UNII: 4X49 Y0 59 6 W) (OCTISALATE - UNII:4X49 Y0 59 6 W)

OCTISALATE

6 .0 0 g in 120 mL

O CTO CRYLENE (UNII: 5A6 8 WGF6 WM) (OCTOCRYLENE - UNII:5A6 8 WGF6 WM)

OCTOCRYLENE

2.40 g in 120 mL

O XYBENZO NE (UNII: 9 5OOS7VE0 Y) (OXYBENZONE - UNII:9 5OOS7VE0 Y)

OXYBENZONE

2.40 g in 120 mL

Inactive Ingredients

Ingredient Name

Stre ng th

.ALPHA.-AMYLCINNAMALDEHYDE (UNII: WC51CA3418 )

ASCO RBYL PALMITATE (UNII: QN8 3US2B0 N)

BENZYL ALCO HO L (UNII: LKG8 49 4WBH)

BUTYLPARABEN (UNII: 3QPI1U3FV8 )

ALKYL ( C12 -15) BENZO ATE (UNII: A9 EJ3J6 1HQ)

CARBO MER 9 3 4 (UNII: Z135WT9 20 8 )

PO LYO XYL 2 0 CETO STEARYL ETHER (UNII: YRC528 SWUY)

CETO STEARYL ALCO HO L (UNII: 2DMT128 M1S)

ETHYLPARABEN (UNII: 14255EXE39 )

GLYCERYL MO NO STEARATE (UNII: 230 OU9 XXE4)

GLYCERYL STEARATE SE (UNII: FCZ5MH78 5I)

ISO BUTYLPARABEN (UNII: 0 QQJ25X58 G)

LINALO O L, ( +/-) - (UNII: D8 1QY6 I8 8 E)

METHYLPARABEN (UNII: A2I8 C7HI9 T)

PEG-10 0 STEARATE (UNII: YD0 1N19 9 9 R)

PHENO XYETHANO L (UNII: HIE49 2ZZ3T)

PRO PYLENE GLYCO L (UNII: 6 DC9 Q16 7V3)

PRO PYLPARABEN (UNII: Z8 IX2SC1OH)

SO DIUM HYDRO XIDE (UNII: 55X0 4QC32I)

SO DIUM CETO STEARYL SULFATE (UNII: 7ZBS0 6 BH4B)

EDETATE SO DIUM (UNII: MP1J8 420 LU)

ALPHA-TO CO PHERO L ACETATE (UNII: 9 E8 X8 0 D2L0 )

WATER (UNII: 0 59 QF0 KO0 R)

Product Characteristics

Color

white

S core

S hap e

S iz e

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:6 30 49 -10 3-23

120 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

0 3/18 /20 14

2

NDC:6 30 49 -10 3-25

9 5 mL in 1 TUBE; Type 0 : No t a Co mbinatio n Pro duct

11/12/20 15

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph no t final

pa rt352

0 3/18 /20 14

Labeler -

European Perfume Works Co. L.L.C (851151050)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Euro pean Perfume Wo rks Co . L.L.C

8 511510 50

ma nufa c ture (6 30 49 -10 3)

European Perfume Works Co. L.L.C

Revised: 5/2017

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