Label: PRO TRIPLE PROTECTION FACTOR BROAD SPECTRUM SPF 50 SUNSCREEN- titanium dioxide, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 67938-2075-1, 67938-2075-2 - Packager: ELIZABETH ARDEN, 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 February 1, 2017
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- Official Label (Printer Friendly)
- Active Ingredients
- Purpose
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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
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Directions For Sunscreen Use:
- Apply liberally 15 minutes before sun exposure
- Reapply:
- At least every 2 hours
- Use a water resistant sunscreen if swimming or sweating
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin 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.
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Inactive Ingredients
WATER/AQUA/EAU, CYCLOPENTASILOXANE, ISODODECANE, C12-15 ALKYL BENZOATE, CAPRYLYL METHICONE, DIMETHICONE, POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE, PENTYLENE GLYCOL, ALUMINUM HYDROXIDE, STEARIC ACID, DISTEARDIMONIUM HECTORITE, RICINOLETH-40, ETHOXYDIGLYCOL, CARNOSINE, ACETYL FARNESYLCYSTEINE, ACRYLATES/ETHYLHEXYL ACRYLATE/DIMETHICONE METHACRYLATE COPOLYMER, ALLYL CAPROATE, ARABIDOPSIS THALIANA EXTRACT, BUTYLENE GLYCOL, CAPRYLYL GLYCOL, CHONDRUS CRISPUS EXTRACT, DIPROPYLENE GLYCOL, ERGOTHIONEINE, ETHYL DECADIENOATE, HDI/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER, HYDROGEN DIMETHICONE, LECITHIN, METHYLDIHYDROJASMONATE, METHYLENEDIOXYPHENYL METHYLPROPANAL, MICROCOCCUS LYSATE, PEG/PPG-18/18 DIMETHICONE, PLANKTON EXTRACT, SILICA, SODIUM HYALURONATE, SODIUM PCA, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, CHLORPHENESIN, PHENOXYETHANOL, POTASSIUM SORBATE, SODIUM DEHYDROACETATE, IRON OXIDES (CI 77491, CI 77492, CI 77499).
- Other Information
- Questions or comments?
- Principal Display Panel - Bottle Label
- Principal Display Panel - Carton Label
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INGREDIENTS AND APPEARANCE
PRO TRIPLE PROTECTION FACTOR BROAD SPECTRUM SPF 50 SUNSCREEN
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67938-2075 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE .25803 g in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE .31416 g in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) ISODODECANE (UNII: A8289P68Y2) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) CAPRYLYL TRISILOXANE (UNII: Q95M2P1KJL) DIMETHICONE (UNII: 92RU3N3Y1O) POLYGLYCERYL-3 POLYDIMETHYLSILOXYETHYL DIMETHICONE (4000 MPA.S) (UNII: RLA2U05Z4Q) PEG-9 POLYDIMETHYLSILOXYETHYL DIMETHICONE (UNII: TYP81E471F) PENTYLENE GLYCOL (UNII: 50C1307PZG) STEARIC ACID (UNII: 4ELV7Z65AP) ALUMINUM HYDROXIDE (UNII: 5QB0T2IUN0) RICINOLETH-40 (UNII: 6S0J4W9IQY) CARNOSINE (UNII: 8HO6PVN24W) DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) HEXAMETHYLENE DIISOCYANATE/TRIMETHYLOL HEXYLLACTONE CROSSPOLYMER (UNII: WB5K9Y35Y9) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) ACETYL FARNESYLCYSTEINE (UNII: KK6984C8O3) FERRIC OXIDE YELLOW (UNII: EX438O2MRT) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PEG/PPG-18/18 DIMETHICONE (UNII: 9H0AO7T794) CHLORPHENESIN (UNII: I670DAL4SZ) FERRIC OXIDE RED (UNII: 1K09F3G675) METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y) ALLYL HEXANOATE (UNII: 3VH84A363D) ETHYL 2,4-DECADIENOATE, (2E,4Z)- (UNII: 79P6KS9Y5Z) DIPROPYLENE GLYCOL (UNII: E107L85C40) 3-(3,4-METHYLENEDIOXYPHENYL)-2-METHYLPROPANAL (UNII: L65EG8H6PA) CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78) FERROSOFERRIC OXIDE (UNII: XM0M87F357) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) BUTYLENE GLYCOL (UNII: 3XUS85K0RA) ARABIDOPSIS THALIANA (UNII: AI3L60HQ81) SODIUM DEHYDROACETATE (UNII: 8W46YN971G) ERGOTHIONEINE (UNII: BDZ3DQM98W) HYALURONATE SODIUM (UNII: YSE9PPT4TH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67938-2075-1 1 in 1 BOX 02/01/2017 1 NDC:67938-2075-2 50 mL in 1 BOTTLE; 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 02/01/2017 Labeler - ELIZABETH ARDEN, INC (849222187)
