Label: DERMA BRITE SPF 35- octinoxate, octisalate, oxybenzone cream

  • NDC Code(s): 67879-308-11, 67879-308-51
  • Packager: PHARMAGEL INTERNATIONAL INC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 27, 2021

If you are a consumer or patient please visit this version.

  • ACTIVE INGREDIENTS

    Octinoxate 7.5%

    Octisalate 5.0%

    Oxybenzone 3.0%

  • 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 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

    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

  • PRINCIPAL DISPLAY PANEL

    DERB_1_RL-1_box_final.jpg

  • INGREDIENTS AND APPEARANCE
    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 not finalpart35206/18/2015
    Labeler - PHARMAGEL INTERNATIONAL INC (603215182)
    Registrant - PHARMAGEL INTERNATIONAL INC (603215182)