Drug Facts

Active Ingredients

Avobenzone 2%, Octinoxate 5%

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 useon damaged or broken skin.

When using this productkeep out of eyes. Rinse with water to remove.

Stop use and ask a doctorif rash occurs.

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

Directions

Apply liberally 15 minutes before sun exposure

reapply: after 40 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

Water, Glyceryl Stearate, Butylene Glycol, Cetyl Alcohol, Cyclopentasiloxane, C12-15 Alkyl Benzoate, Octyldodecyl Neopentanoate, Silica, Butyrospermum Parkii (Shea) Butter, Emu Oil, Glycerin, PEG-100 Stearate, Polyglyceryl-3 Laurate, Taraktogenos Kurzii Seed Oil, Aloe Barbadensis Leaf Extract, Anthemis Nobilis Flower Extract, Camellia Sinensis Leaf Extract, Panax Ginseng Root Extract, Allantoin, Carbomer, Ceteth-20, Disodium EDTA, Ethylhexylglycerin, O-Cymen-5-Ol, Tetrahexyldecyl Ascorbate, Tocopheryl Acetate, Fragrance, Steareth-2, Steareth-20, Triethanolamine, Phenoxyethanol.

Other information

protect this product from excessive heat and direct sun

Questions or comments?

Call toll free at 866-452-7956.

DISTRIBUTED IN U.S.A. BY
ERNO LASZLO NEW YORK, NY 10001

Product label

PHELITYL DAY SPF 15
avobenzone and octinoxate lotion

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:57913-2832
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	20 mg in 1 mL
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
CETYL ALCOHOL (UNII: 936JST6JCN)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
SHEA BUTTER (UNII: K49155WL9Y)
EMU OIL (UNII: 344821WD61)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-100 STEARATE (UNII: YD01N1999R)
MYRISTYL ALCOHOL (UNII: V42034O9PU)
COCO GLUCOSIDE (UNII: ICS790225B)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
DIMETHICONE (UNII: 92RU3N3Y1O)
HYDNOCARPUS KURZII SEED OIL (UNII: N757YEZ18Q)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CHAMAEMELUM NOBILE FLOWER (UNII: O2T154T6OG)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
ASIAN GINSENG (UNII: CUQ3A77YXI)
ALLANTOIN (UNII: 344S277G0Z)
CETETH-20 (UNII: I835H2IHHX)
EDETATE DISODIUM (UNII: 7FLD91C86K)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
STEARETH-2 (UNII: V56DFE46J5)
STEARETH-20 (UNII: L0Q8IK9E08)
TROLAMINE (UNII: 9O3K93S3TK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:57913-2832-9	1 in 1 CARTON	04/10/2013
1		90 mL in 1 JAR; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC Monograph Drug	M020	04/10/2013

Labeler - Erno Laszlo, Inc. (098821031)

Name	Address	ID/FEI	Business Operations
Establishment
Mana Products		078870292	manufacture(57913-2832)

Phelityl Day SPF 15