PHELITYL DAY SPF 15 cream

PHELITYL DAY SPF 15 by

Drug Labeling and Warnings

PHELITYL DAY SPF 15 by is a Otc medication manufactured, distributed, or labeled by MANA PRODUCTS, INC., MANA PRODUCTS, INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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 use on damaged or broken skin.
• When using this product keep out of eyes. Rinse with water to remove.

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

INDICATIONS & USAGE

Stop use and ask a doctor if rash occurs.

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.

Product label

INGREDIENTS AND APPEARANCE

PHELITYL DAY SPF 15 
phelityl day spf 15 cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 59735-475
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	5 g  in 100 g
AVOBENZONE (UNII: G63QQF2NOX) (AVOBENZONE - UNII:G63QQF2NOX)	AVOBENZONE	2 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CETYL ALCOHOL (UNII: 936JST6JCN)
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)
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)
CETETH-20 (UNII: I835H2IHHX)
WATER (UNII: 059QF0KO0R)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T)
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)
EDETATE DISODIUM (UNII: 7FLD91C86K)
STEARETH-20 (UNII: L0Q8IK9E08)
TROLAMINE (UNII: 9O3K93S3TK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
O-CYMEN-5-OL (UNII: H41B6Q1I9L)
TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
STEARETH-2 (UNII: V56DFE46J5)

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 59735-475-01	1 in 1 CARTON	04/10/2013
1		90 g in 1 JAR; Type 0: Not a Combination Product

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

Labeler - MANA PRODUCTS, INC. (078870292)

Establishment
Name	Address	ID/FEI	Business Operations
MANA PRODUCTS, INC		032870270	manufacture(59735-475)

Establishment
Name	Address	ID/FEI	Business Operations
MANA PRODUCTS, INC.		078870292	manufacture(59735-475)