NDC | 67226-2231-6 |
Set ID | 1c2425da-b35a-460e-8fef-675e367ce615 |
Category | HUMAN OTC DRUG LABEL |
Packager | Vivier Pharma Inc |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- DRUG FACTS
- ACTIVE INGREDIENTS
- USES
-
WARNINGS
For external use only
- The sun may cause sunburn, premature aging of the skin and skin cancer. Avoiding the sun, wearing protective clothing and
regular use of sunscreens over the years may reduce the chance of these harmful effects.
- The sun may cause sunburn, premature aging of the skin and skin cancer. Avoiding the sun, wearing protective clothing and
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DIRECTIONS
- Apply daily to face, neck and chest.
- Apply liberally and evenly 15 minutes before sun exposure.
- Reapply at least every 2 hours or as needed after towel drying, perspiring heavily or washing.
- For use on children less than 6 months of age, consult a healthcare practitioner.
- Use a water resistant sunscreen if swimming or sweating.
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INACTIVE INGREDIENTS:
ALUMINA, AMMONIUM ACRYLOYLDIMETHYLTAURATE, BIS PEG/PPG-16-16 PEG/PPG16/16 DIMETHICONE, BUTYLPARABEN, C12-15 ALKYL
BENZOATE, CAMELIA SINENSIS (GREEN TEA) EXTRACT, CAPRYLIC/- CAPRIC TRIGLYCERIDE, CETEARETH 20, CETEARYL ALCOHOL, CETYL
DIMETHICONE, CITRUS MEDICA LIMONUM (LEMON BIOFLAVANOIDS) PEEL EXTRACT, CYCLOMETHICONE, DIMETHICONE, DIPROPYLENE GLYCOL DIBENZOATE, EICOSENE COPOLYMER, ETHYLPARABEN, GLYCERIN, GLYCERYL STEARATE, ISOPROPYL TITANIUM TRIISOSTEARATE, METHYLPARABEN, PHENOXYETHANOL, POLYHYDROXYSTEARIC ACID, POLYSORBATE 20, PPG-15 STEARYL ETHER BENZOATE, PROPYLPARABEN, PYRUS MALUS (APPLE) FRUIT EXTRACT, SACCHARUM OFFICINARUM (SUGAR CANE) EXTRACT, SODIUM ASCORBYL PHOSPHATE, TOCOPHERYL ACETATE, TRIETHOXYCAPRYLYLSILANE, WATER/EAU, XANTHAN GUM. - Questions?
- Package Labeling:
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INGREDIENTS AND APPEARANCE
TRIPLE PROTECTION SUNSCREEN BROAD SPECTRUM SPF 30
titanium dioxide, zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:67226-2231 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 100 mg in 1 mL ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 80 mg in 1 mL Inactive Ingredients Ingredient Name Strength ALUMINUM OXIDE (UNII: LMI26O6933) AMMONIUM ACRYLOYLDIMETHYLTAURATE (UNII: KBC00G95HI) BUTYLPARABEN (UNII: 3QPI1U3FV8) GREEN TEA LEAF (UNII: W2ZU1RY8B0) POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) LEMON PEEL (UNII: 72O054U628) CYCLOMETHICONE (UNII: NMQ347994Z) DIMETHICONE (UNII: 92RU3N3Y1O) DIPROPYLENE GLYCOL DIBENZOATE (UNII: 6OA5ZDY41O) ETHYLPARABEN (UNII: 14255EXE39) GLYCERIN (UNII: PDC6A3C0OX) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) METHYLPARABEN (UNII: A2I8C7HI9T) PHENOXYETHANOL (UNII: HIE492ZZ3T) POLYSORBATE 20 (UNII: 7T1F30V5YH) PPG-15 STEARYL ETHER BENZOATE (UNII: 80D2J6361M) PROPYLPARABEN (UNII: Z8IX2SC1OH) APPLE (UNII: B423VGH5S9) SUGARCANE (UNII: 81H2R5AOH3) SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) WATER (UNII: 059QF0KO0R) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:67226-2231-6 1 in 1 CARTON 11/11/2017 1 60 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part352 11/11/2017 Labeler - Vivier Pharma Inc (250996550)