TROPICSURF EXTREME PROTECTION SPF50- octocrylene, zinc oxide lotion 
PALMER SURF LLC (DBA X3EMBRANDS)

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.

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ACTIVE INGREDIENT

DIRECTIONS

SUN PROTECTION MEASURES:

PURPOSE:

Uses:

WARNINGS

FOR EXTERNAL USE ONLY

DO NOT USE ON DAMAGED OR BROKEN SKIN

WHEN USING THIS PRODUCT

STOP USE AND ASK A DOCTOR IF

KEEP OUT OF REACH OF CHILDREN.

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)

SPF50

TROPICSURF EXTREME PROTECTION SPF50 
octocrylene, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70884-102
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
OCTOCRYLENE (UNII: 5A68WGF6WM) (OCTOCRYLENE - UNII:5A68WGF6WM) OCTOCRYLENE7.5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION10.5 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70884-102-1145 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2016
2NDC:70884-102-0390 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2016
3NDC:70884-102-16195 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2016
4NDC:70884-102-13390 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2016
5NDC:70884-102-30960 mL in 1 BOTTLE; Type 0: Not a Combination Product08/04/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/04/2016
Labeler - PALMER SURF LLC (DBA X3EMBRANDS) (080315280)
Registrant - PALMER SURF LLC (DBA X3EMBRANDS) (080315280)

Revised: 12/2017
Document Id: 7d9cd804-b429-4a20-b4cd-be3b07900e4e
Set id: 5f91b1c1-26be-45fc-90e9-d258f8326666
Version: 5
Effective Time: 20171218
 
PALMER SURF LLC (DBA X3EMBRANDS)