TROPICSURF EXTREME PROTECTION SPF30-ULTRA- titanium dioxide, 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 INGREDIENTS

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, CAPRYLIC/CAPRIC TRIGLYCERIDE, GLYCERIN, CETEARYL ALCOHOL, STEARETH-2, VP/HEXADECENE COPOLYMER,

STEREATH-21, DIMETHICONE, POLYHYDROXYSTEARIC ACID, ALOE BARBADENSIS LEAF EXTRACT, CAMELLIA OLEIFERA

LEAF EXTRACT, PLEIOGYNIUM TIMORIENSE FRUIT EXTRACT, PODOCARPS ELATUS FRUIT EXTRACT, TERMINALIA FERDINANDIANA

FRUIT EXTRACT, ADANSONIA DIGITATA SEED OIL, ASTROCARYUM TUCUMA SEED BUTTER, MADACAMIA TERNIFOLIA NUT OIL,

DIPOTASSIUM GLYCYRRHIZATE, ALUMINA, STEARIC ACID, SODIUM STEAROYL GLUTAMATE, TRIETHOXYCAPRYLYLSILANE,

PROPANEDIOL, CAPRYLHYDROXAMIC ACID, DISODIUM EDTA, XANTHAN GUM, CAPRYLYL GLYCOL, ALCOHOL DENAT.,

FRAGRANCE (PARFUM)

SPF30 ULTRA

TROPICSURF EXTREME PROTECTION SPF30-ULTRA 
titanium dioxide, zinc oxide lotion
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70884-101
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE4.5 g  in 100 mL
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION8.7 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
GLYCERIN (UNII: PDC6A3C0OX)  
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
STEARETH-2 (UNII: V56DFE46J5)  
VINYLPYRROLIDONE/HEXADECENE COPOLYMER (UNII: KFR5QEN0N9)  
STEARETH-21 (UNII: 53J3F32P58)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
CAMELLIA OLEIFERA LEAF (UNII: 5077EL0C60)  
PLUM (UNII: 67M3EQ6BE1)  
PODOCARPUS ELATUS WHOLE (UNII: H38807Y47G)  
KAKADU PLUM (UNII: 0ZQ1D2FDLI)  
ADANSONIA DIGITATA SEED OIL (UNII: 77MKL7AR5I)  
ASTROCARYUM ACULEATUM SEED OIL (UNII: JUP28JPX3K)  
MACADAMIA OIL (UNII: 515610SU8C)  
GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SODIUM STEAROYL GLUTAMATE (UNII: 65A9F4P024)  
TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E)  
PROPANEDIOL (UNII: 5965N8W85T)  
CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W)  
DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
XANTHAN GUM (UNII: TTV12P4NEE)  
CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
ALCOHOL (UNII: 3K9958V90M)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70884-101-1145 mL in 1 BOTTLE; Type 0: Not a Combination Product08/03/2016
2NDC:70884-101-0390 mL in 1 BOTTLE; Type 0: Not a Combination Product08/03/2016
3NDC:70884-101-16195 mL in 1 BOTTLE; Type 0: Not a Combination Product08/03/2016
4NDC:70884-101-13390 mL in 1 BOTTLE; Type 0: Not a Combination Product08/03/2016
5NDC:70884-101-32960 mL in 1 BOTTLE; Type 0: Not a Combination Product08/03/2016
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35208/03/2016
Labeler - PALMER SURF LLC (DBA X3EMBRANDS) (080315280)
Registrant - PALMER SURF LLC (DBA X3EMBRANDS) (080315280)

Revised: 11/2017
Document Id: 132b48fc-b3c3-4cd3-8b8c-89b1dff3992f
Set id: 5a18cf0c-90d1-428d-89b5-faf064b996d7
Version: 4
Effective Time: 20171107
 
PALMER SURF LLC (DBA X3EMBRANDS)