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
Drug Label Information
Updated January 7, 2024
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- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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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
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INGREDIENTS AND APPEARANCE
DERMA BRITE SPF 35
octinoxate, octisalate, oxybenzone creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67879-308 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 g in 100 g OXYBENZONE (UNII: 95OOS7VE0Y) (OXYBENZONE - UNII:95OOS7VE0Y) OXYBENZONE 3 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:67879-308-51 1 in 1 BOX 06/13/2016 1 NDC:67879-308-11 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 Drug M020 06/18/2015 Labeler - PHARMAGEL INTERNATIONAL INC (603215182)
