DERMA FADE- octinoxate, octisalate, oxybenzone cream 
PHARMAGEL INTERNATIONAL INC

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PHARMAGEL - DERMA FADE (67879-301)

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. 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)

DermaFade_final_box

DF_PF_final_rev

DERMA FADE 
octinoxate, octisalate, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67879-301
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTINOXATE (UNII: 4Y5P7MUD51) (OCTINOXATE - UNII:4Y5P7MUD51) OCTINOXATE7.5 g  in 100 g
OCTISALATE (UNII: 4X49Y0596W) (OCTISALATE - UNII:4X49Y0596W) OCTISALATE5 g  in 100 g
OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE3 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67879-301-511 in 1 BOX06/18/2015
1NDC:67879-301-1156 g in 1 JAR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02006/18/2015
Labeler - PHARMAGEL INTERNATIONAL INC (603215182)

Revised: 1/2024
Document Id: 0e5fa1ca-f9b7-f8a3-e063-6394a90af93f
Set id: 08c7bbf0-5a18-405d-a0bb-a912926fc27b
Version: 6
Effective Time: 20240107
 
PHARMAGEL INTERNATIONAL INC