Label: TROPICSURF EXTREME PROTECTION SPF50- octocrylene, zinc oxide lotion
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Contains inactivated NDC Code(s)
NDC Code(s): 70884-102-03, 70884-102-11, 70884-102-13, 70884-102-16, view more70884-102-30 - Packager: PALMER SURF LLC (DBA X3EMBRANDS)
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph 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 December 18, 2017
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
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DOSAGE & ADMINISTRATION
DIRECTIONS
- APPLY LIBERALLY 15 MINUTES PRIOR TO SUN EXPOSURE. REAPPLY AFTER
- 80 MINUTES OF SWIMMING OR SWEATING; IMMEDIATELY AFTER TOWEL
- DRYING; AND, AT LEAST EVERY 2 HOURS.
SUN PROTECTION MEASURES:
- SPENDING TIME IN THE SUN INCREASES YOUR RISKI OF SKIN CANCER AND EARLY SKIN
- AGING. TO DECREASE THIS RISK, REGULARLY USE A SUNSCREEN WITH A BROAD
- SPECTRUM SPF VALUE OF 15 OR HIGHER AND OTHER SUN PROTECTION MEASURES
- INCLUDING: LIMIT TIME IN THE SUN, ESPECIALLY FROM 10 AM TO 2 PM; WEAR
- LONG-SLEEVE SHIRTS, PANTS, HATS AND SUNGLASSES; CHILDREN UNDER 6 MOS.
- OF AGE, ASK A DOCTOR
- PURPOSE
- INDICATIONS & USAGE
- WARNINGS
- WHEN USING
- STOP USE
- KEEP OUT OF REACH OF CHILDREN
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INACTIVE INGREDIENT
INACTIVE INGREDIENTS:
WATER/AQUA/EAU, OCTYLDODECYL NEOPENTANOATE, DIMETHICONE, CETEARYL ALCOHOL, ACRYLATES COPOLYMER,
PEG-100 STEARATE, GLYCERYL STEARATE, PENTYLENE GLYCOL, PHENYL TRIMETHICONE, GLYCERIN, CYCLOPENTASILOXANE,
TRIMETHYLSILOXYSILICATE, PEG-40 STEARATE, ALOE BARBADENSIS LEAF JUICE, CAMELLIA OLEIFERA LEAF JUICE,
ASTROCARYUM TUCUMA SEED BUTTER, MACADAMIA TERNIFOLIA SEED OIL, ADANSONIA DIGITATA SEED OIL, MANGIFERA
INDICA (MANGO) SEED BUTTER, COCO GLUCOSIDE, TOCOPHERYL ACETATE, HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL
TAURATE COPOLYMER, SQUALANE, POLYSORBATE 60, POLYSILICONE-11, SODIUM POLYACRYLATE, XANTHAN GUM,
DICETYL PHOSPHATE, CETTH-10 PHOSPHATE, AMINOMETHYLPROPANOL, DISODIUM EDTA, CAPRYLYL GLYCOL, PHENOXYETHANOL,
CHLOPHENESIN, BENXYL CINNAMATE, COUMARIN, LIMONENE, HEXYL CINNAMAL, FRAGRANCE (PARFUM)
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
TROPICSURF EXTREME PROTECTION SPF50
octocrylene, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70884-102 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE 7.5 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 10.5 g in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) OCTYLDODECYL NEOPENTANOATE (UNII: X8725R883T) DIMETHICONE (UNII: 92RU3N3Y1O) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 71DD5V995L) PEG-100 STEARATE (UNII: YD01N1999R) GLYCERYL STEARATE SE (UNII: FCZ5MH785I) PENTYLENE GLYCOL (UNII: 50C1307PZG) PHENYL TRIMETHICONE (UNII: DR0K5NOJ4R) GLYCERIN (UNII: PDC6A3C0OX) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) TRIMETHYLSILOXYSILICATE (M/Q 0.6-0.8) (UNII: 5041RX63GN) PEG-40 STEARATE (UNII: ECU18C66Q7) ALOE VERA LEAF (UNII: ZY81Z83H0X) CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60) ASTROCARYUM ACULEATUM SEED OIL (UNII: JUP28JPX3K) MACADAMIA OIL (UNII: 515610SU8C) ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I) MANGIFERA INDICA SEED BUTTER (UNII: 4OXD9M35X2) COCO GLUCOSIDE (UNII: ICS790225B) ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4) SQUALANE (UNII: GW89575KF9) POLYSORBATE 60 (UNII: CAL22UVI4M) DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) XANTHAN GUM (UNII: TTV12P4NEE) DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N) CETETH-10 PHOSPHATE (UNII: 4E05O5N49G) AMINOMETHYLPROPANOL (UNII: LU49E6626Q) DISODIUM EDTA-COPPER (UNII: 6V475AX06U) CAPRYLYL GLYCOL (UNII: 00YIU5438U) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHLORPHENESIN (UNII: I670DAL4SZ) BENZYL CINNAMATE (UNII: V67O3RO97U) COUMARIN (UNII: A4VZ22K1WT) LIMONENE, (+)- (UNII: GFD7C86Q1W) .ALPHA.-HEXYLCINNAMALDEHYDE (UNII: 7X6O37OK2I) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70884-102-11 45 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/04/2016 2 NDC:70884-102-03 90 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/04/2016 3 NDC:70884-102-16 195 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/04/2016 4 NDC:70884-102-13 390 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/04/2016 5 NDC:70884-102-30 960 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/04/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/04/2016 Labeler - PALMER SURF LLC (DBA X3EMBRANDS) (080315280) Registrant - PALMER SURF LLC (DBA X3EMBRANDS) (080315280)
