NDC | 70884-101-03, 70884-101-11, 70884-101-13, 70884-101-16, 70884-101-32 |
Set ID | 5a18cf0c-90d1-428d-89b5-faf064b996d7 |
Category | HUMAN OTC DRUG LABEL |
Packager | PALMER SURF LLC (DBA X3EMBRANDS) |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- ACTIVE INGREDIENTS
-
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
- USES
- WARNINGS
- WHEN USING
- STOP USE
- 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)
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
TROPICSURF EXTREME PROTECTION SPF30-ULTRA
titanium dioxide, zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70884-101 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 4.5 g in 100 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 8.7 g in 100 mL Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:70884-101-11 45 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/03/2016 2 NDC:70884-101-03 90 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/03/2016 3 NDC:70884-101-16 195 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/03/2016 4 NDC:70884-101-13 390 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/03/2016 5 NDC:70884-101-32 960 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/03/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part352 08/03/2016 Labeler - PALMER SURF LLC (DBA X3EMBRANDS) (080315280) Registrant - PALMER SURF LLC (DBA X3EMBRANDS) (080315280)