DERMA FADE- octinoxate, octisalate, oxybenzone cream

DERMA FADE by

Drug Labeling and Warnings

DERMA FADE by is a Otc medication manufactured, distributed, or labeled by PHARMAGEL INTERNATIONAL INC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 3.0%

PURPOSE

Sunscreen

USES

Lightens the appearance of age spots & skin discoloration. Provides moderate protections against sunburn.

WARNINGS

Warnings using this product – For external use only. Avoid contact with eyes. If product gets into the eyes, rinse thoroughly with water. Do not use on children under 12 years of age unless directed by a doctor. Stop use & consult a doctor if rash or irritation develops and persists.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.

DIRECTIONS

Apply to age spots and skin discoloration. Can be used as a full face moisturizing treatment and sunscreen before sun exposure.

INACTIVE INGREDIENTS:

ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER, ALLANTOIN, BIOTIN, BUTYLENE GLYCOL, CAMELLIA SINENSIS (GREEN TEA) LEAF EXTRACT, CAPRYLYL GLYCOL, CETEARYL ALCOHOL, CITRIC ACID, CITRUS UNSHIU PEEL EXTRACT, CYPERUS ROTUNDUS ROOT EXTRACT, DIMETHICONE, DISODIUM EDTA, ETHYLHEXYL PALMITATE, ETHYLHEXYLGLYCERIN, FRAGRANCE (PARFUM), GLYCERIN, GLYCERYL STEARATE, GLYCOLIC ACID, GLYCYRRHIZA GLABRA (LICORICE) ROOT EXTRACT, HEXYLENE GLYCOL, HYDROXYETHYLCELLULOSE, KOJIC ACID, LACTIC ACID, MAGNESIUM ASCORBYL PHOSPHATE, MORUS ALBA LEAF EXTRACT, MYRISTYL LAURATE, MYRISTYL MYRISTATE, NIACIN, PANTHENOL, PEG-100 STEARATE, PHENOXYETHANOL, PHYLLANTHUS EMBLICA FRUIT EXRACT, PROPYLENE GLYCOL, RED 40 (CI 16035), SODIUM CITRATE, STEARIC ACID, TETRASODIUM EDTA, TRIETHANOLAMINE, UNDECYLENIC ACID, UNDECYLENOYL PHENYLALANINE, WATER (AQUA), YELLOW 6 (CI 15985)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DERMA FADE 
octinoxate, octisalate, oxybenzone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 67879-301
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51)	OCTINOXATE	7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W)	OCTISALATE	5.0 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y)	OXYBENZONE	3.0 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)
ALLANTOIN (UNII: 344S277G0Z)
BIOTIN (UNII: 6SO6U10H04)
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TANGERINE PEEL (UNII: JU3D414057)
CYPERUS ROTUNDUS TUBER (UNII: 4B51SRR959)
DIMETHICONE (UNII: 92RU3N3Y1O)
EDETATE DISODIUM (UNII: 7FLD91C86K)
ETHYLHEXYL PALMITATE (UNII: 2865993309)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
GLYCOLIC ACID (UNII: 0WT12SX38S)
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)
HEXYLENE GLYCOL (UNII: KEH0A3F75J)
HYDROXYETHYL CELLULOSE (3000 MPA.S AT 1%) (UNII: 7Q6P4JN1QT)
KOJIC ACID (UNII: 6K23F1TT52)
LACTIC ACID (UNII: 33X04XA5AT)
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)
MORUS ALBA LEAF (UNII: M8YIA49Q2P)
MYRISTYL LAURATE (UNII: 58U0NZN2BT)
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)
NIACIN (UNII: 2679MF687A)
PANTHENOL (UNII: WV9CM0O67Z)
PEG-100 STEARATE (UNII: YD01N1999R)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
STEARIC ACID (UNII: 4ELV7Z65AP)
EDETATE SODIUM (UNII: MP1J8420LU)
TROLAMINE (UNII: 9O3K93S3TK)
UNDECYLENIC ACID (UNII: K3D86KJ24N)
UNDECYLENOYL GLYCINE (UNII: 4D20464K2J)
WATER (UNII: 059QF0KO0R)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 67879-301-51	1 in 1 BOX	06/18/2015
1	NDC: 67879-301-11	56 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 not final	part352	06/18/2015

Labeler - PHARMAGEL INTERNATIONAL INC (603215182)

Registrant - PHARMAGEL INTERNATIONAL INC (603215182)