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

EAD Kids by

Drug Labeling and Warnings

EAD Kids by is a Otc medication manufactured, distributed, or labeled by EUROPEAN PERFUME WORKS CO. LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients:

Avobenzone  3.0%
Homosalate  10.0%
Octocrylene  5.0%
Octisalate     5.0%
Oxybenzone 5.0%

Purpose

Sunscreen

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

Uses

• helps to 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

Acrylates/C10-30 alkyl acrylate crosspolymer, ascorbyl palmitate, aloe barbadensis leaf juice, butylparaben, C12-15 alkyl benzoate, cetearyl alcohol, carbomer, ceteareth-20, ethylparaben, fragrance, glyceryl stearate SE, glyceryl stearate, hydorxypropyl methylcellulose, isobutylparaben, linalool, methylparaben, propylene glycol, PEG-100 stearate, PEG-60 almond glycerides, phenoxyethanol, propylparaben, rosa moschata seed oil, sodium cetearyl sulfate, sodium hydroxide, tocopheryl acetate, tetrasodium EDTA, water

Other Information

protect the product from excessive heat and direct sun

Questions or comments?

Call toll free 1-844-875-4176

Packaging

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 63049-105
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2.64 g  in 88 mL
HOMOSALATE (UNII: V06SV4M95S) (HOMOSALATE - UNII:V06SV4M95S)	HOMOSALATE	8.80 g  in 88 mL
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM)	OCTOCRYLENE	4.40 g  in 88 mL
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	4.40 g  in 88 mL
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	4.40 g  in 88 mL

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ASCORBYL PALMITATE (UNII: QN83US2B0N)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
BUTYLPARABEN (UNII: 3QPI1U3FV8)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
ETHYLPARABEN (UNII: 14255EXE39)
GLYCERYL STEARATE SE (UNII: FCZ5MH785I)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ISOBUTYLPARABEN (UNII: 0QQJ25X58G)
LINALOOL, (+/-)- (UNII: D81QY6I88E)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PEG-100 STEARATE (UNII: YD01N1999R)
PEG-60 ALMOND GLYCERIDES (UNII: 4Y0E651N0F)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
ROSA MOSCHATA SEED OIL (UNII: T031ZE559T)
SODIUM CETOSTEARYL SULFATE (UNII: 7ZBS06BH4B)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
EDETATE SODIUM (UNII: MP1J8420LU)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63049-105-24	88 mL in 1 TUBE; Type 0: Not a Combination Product	12/21/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part352	12/21/2014

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

Establishment
Name	Address	ID/FEI	Business Operations
European Perfume Works Co.L.L.C		851151050	manufacture(63049-105)