DERMA BRITE SPF 35- octinoxate, octisalate, oxybenzone cream 
PHARMAGEL INTERNATIONAL INC

----------

PHARMAGEL - DERMA BRITE (67879-308)

ACTIVE INGREDIENTS

Octinoxate 7.5%

Octisalate 5.0%

Oxybenzone 3.0%

PURPOSE

Sunscreen

USES

WARNINGS

For external use only.

Do not use on damaged or broken skin.

When using product keep out of eyes. Rinse with warm water to remove.

Stop use and ask doctor if 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 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 (aqua, eau), citrus unshiu peel extract, ethylhexyl palmitate, propylene glycol, glyceryl stearate, peg-100 stearate, cetearyl alcohol, dimethicone, palmitic acid, phenoxyethanol, stearic acid, myristyl myristate, acrylates/c10-30 alkyl acrylate crosspolymer, caprylyl glycol, hydroxyethylcellulose, triethanolamine, glycerin, ethylhexylglycerin, allantoin, hexylene glycol, myristyl laurate, panthenol, tetrasodium edta, fragrance (parfum), glycolic acid, butylene glycol, morus alba leaf extract, myristic acid, kojic acid, magnesium ascorbyl phosphate, niacin, phyllanthus emblica fruit exract, undecylenoyl phenylalanine, glycyrrhiza glabra (licorice) root extract, arachidic acid, camellia sinensis (green tea) leaf extract, bht, potassium sorbate, cyperus rotundus root extract, limonene, sodium citrate, linalool, citric acid, citronellol, sodium benzoate, lactic acid, yellow 6 (ci 15985), biotin, red 40 (ci 16035), undecylenic acid, chlorphenesin, benzoic acid, sorbic acid

DERB_1_RL-1_box_final.jpg

DERMA BRITE  SPF 35
octinoxate, octisalate, oxybenzone cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67879-308
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
WATER (UNII: 059QF0KO0R)  
TANGERINE PEEL (UNII: JU3D414057)  
ETHYLHEXYL PALMITATE (UNII: 2865993309)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
PEG-100 STEARATE (UNII: YD01N1999R)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
PALMITIC ACID (UNII: 2V16EO95H1)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
MYRISTYL MYRISTATE (UNII: 4042ZC00DY)  
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)  
TROLAMINE (UNII: 9O3K93S3TK)  
GLYCERIN (UNII: PDC6A3C0OX)  
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
ALLANTOIN (UNII: 344S277G0Z)  
HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
MYRISTYL LAURATE (UNII: 58U0NZN2BT)  
PANTHENOL (UNII: WV9CM0O67Z)  
EDETATE SODIUM (UNII: MP1J8420LU)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
MORUS ALBA LEAF (UNII: M8YIA49Q2P)  
MYRISTIC ACID (UNII: 0I3V7S25AW)  
KOJIC ACID (UNII: 6K23F1TT52)  
MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5)  
NIACIN (UNII: 2679MF687A)  
PHYLLANTHUS EMBLICA FRUIT (UNII: YLX4CW2576)  
UNDECYLENOYL PHENYLALANINE (UNII: 271P08C6OD)  
GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
ARACHIDIC ACID (UNII: PQB8MJD4RB)  
GREEN TEA LEAF (UNII: W2ZU1RY8B0)  
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
CYPERUS ROTUNDUS ROOT (UNII: 4B51SRR959)  
LIMONENE, (+)- (UNII: GFD7C86Q1W)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
LINALOOL, (+)- (UNII: F4VNO44C09)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
.BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
LACTIC ACID (UNII: 33X04XA5AT)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
BIOTIN (UNII: 6SO6U10H04)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
UNDECYLENIC ACID (UNII: K3D86KJ24N)  
CHLORPHENESIN (UNII: I670DAL4SZ)  
BENZOIC ACID (UNII: 8SKN0B0MIM)  
SORBIC ACID (UNII: X045WJ989B)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:67879-308-511 in 1 BOX06/13/2016
1NDC:67879-308-1156 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: 0e5f77f3-1ac4-fdf2-e063-6394a90aabcf
Set id: fe10912e-00e3-406c-a80c-d9c991dc9f8b
Version: 5
Effective Time: 20240107
 
PHARMAGEL INTERNATIONAL INC