TROPICSURF EXTREME PROTECTION SPF50- octocrylene, zinc oxide lotion

TROPICSURF EXTREME PROTECTION SPF50 by

Drug Labeling and Warnings

TROPICSURF EXTREME PROTECTION SPF50 by is a Otc medication manufactured, distributed, or labeled by PALMER SURF LLC (DBA X3EMBRANDS). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT

• OCTOCRYLENE  7.5%
• ZINC OXIDE      10.5%

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

PURPOSE:

• SUNSCREEN

INDICATIONS & USAGE

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

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE ON DAMAGED OR BROKEN SKIN

WHEN USING

WHEN USING THIS PRODUCT

• KEEP OUT OF THE EYES.
• RINSE WITH WATER TO REMOVE

STOP USE

STOP USE AND ASK A DOCTOR IF

• 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.

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

INGREDIENTS AND APPEARANCE

TROPICSURF EXTREME PROTECTION SPF50 
octocrylene, zinc oxide lotion

Product 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)