NDC | 42508-205-19 |
Set ID | 6bde34c6-0a62-63e1-e053-2991aa0a635f |
Category | HUMAN OTC DRUG LABEL |
Packager | Arbonne International, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number | PART352 |
- Drug Facts
- Active Ingredients
- Purpose
- PURPOSE
- Uses
- Warnings
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Directions
For sunscreen use:
- apply liberally and evenly 15 minutes before sun exposure
- reapply at least every 2 hours
- use a water-resistant sunscreen if swimming or sweating
- children under 6 months of age; ask a doctor
- Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regulary 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 a.m.-2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- KEEP OUT OF REACH OF CHILDREN
- Other information
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Inactive ingredients
water, ethylhexyl palmitate, caprylic/capric triglyceride, cyclopentasiloxane, diisopropyl sebacate, isonoyl isononanoate, polyglyceryl-6 polyricinoleate, polymethylsilsesquioxane, glycerin, argania spinosa kernel oil, polyglyceryl-2 isostearate, tocopheryl acetate, silica, caesalpinia spinosa fruit extract, vaccinium vitis-idaea fruit ectract, kappaphycus alvarezii extract, terminalia ferdinandiana fruit extract, chlorella vulgaris extract, aloe barbadensis leaf juice powder, raspberry seed oil/tocopheryl succinate aminopropanediol esters, olive oil decyl esters, hydrolyzed pea protein, sea salt, squalene, saccharide isomerate, bisabolol, isopropyl myristate, hydrogenated castor oil, xanthan gum, gluconolactone, calcium gluconate, hydrated silica, tocopherol, sodium chloride, magnesium stearate, disteardimonium hectorite, stearalkonium hectorite, propylene carbonate, polyhydroxystearic acid, bentonite, alumina, isopropyl titanium triisostearate, lactic acid, citric acid, phenoxyethanol, potassium sorbate, sodium benzoate, mica, iron oxides (CI 77491, CI 77492, CI 77499), titanium dioxide (CI 77891).
- Questions or comments?
- Principle Display Panel
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INGREDIENTS AND APPEARANCE
RE9 ADVANCED PREPWORK SOFT FOCUS VEIL BROAD SPECTRUM SPF30 SUNSCREEN
zinc oxide, titanium dioxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42508-205 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength TITANIUM DIOXIDE (UNII: 15FIX9V2JP) (TITANIUM DIOXIDE - UNII:15FIX9V2JP) TITANIUM DIOXIDE 2.5 mg in 100 mg ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 7.2 mg in 100 mg Inactive Ingredients Ingredient Name Strength FERRIC OXIDE YELLOW (UNII: EX438O2MRT) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FERROSOFERRIC OXIDE (UNII: XM0M87F357) TOCOPHEROL (UNII: R0ZB2556P8) SODIUM CHLORIDE (UNII: 451W47IQ8X) ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS) HYDROGENATED CASTOR OIL (UNII: ZF94AP8MEY) GLUCONOLACTONE (UNII: WQ29KQ9POT) CALCIUM GLUCONATE (UNII: SQE6VB453K) HYDRATED SILICA (UNII: Y6O7T4G8P9) MAGNESIUM STEARATE (UNII: 70097M6I30) STEARALKONIUM HECTORITE (UNII: OLX698AH5P) PROPYLENE CARBONATE (UNII: 8D08K3S51E) BENTONITE (UNII: A3N5ZCN45C) ALUMINUM OXIDE (UNII: LMI26O6933) ISOPROPYL TITANIUM TRIISOSTEARATE (UNII: 949E3KBJ1I) PHENOXYETHANOL (UNII: HIE492ZZ3T) SODIUM BENZOATE (UNII: OJ245FE5EU) MICA (UNII: V8A1AW0880) FERRIC OXIDE RED (UNII: 1K09F3G675) POLYGLYCERYL-2 MONOISOSTEARATE (UNII: 7B8OE71MQC) ARGAN OIL (UNII: 4V59G5UW9X) LINGONBERRY (UNII: 0UNK9RZQ7X) SEA SALT (UNII: 87GE52P74G) SQUALENE (UNII: 7QWM220FJH) LEVOMENOL (UNII: 24WE03BX2T) XANTHAN GUM (UNII: TTV12P4NEE) DISTEARDIMONIUM HECTORITE (UNII: X687XDK09L) ETHYLHEXYL PALMITATE (UNII: 2865993309) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) CYCLOMETHICONE 5 (UNII: 0THT5PCI0R) DIISOPROPYL SEBACATE (UNII: J8T3X564IH) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) KAPPAPHYCUS ALVAREZII (UNII: T479H08K2O) KAKADU PLUM (UNII: 0ZQ1D2FDLI) CHLORELLA VULGARIS (UNII: RYQ4R60M02) ALOE VERA LEAF (UNII: ZY81Z83H0X) OLIVE OIL DECYL ESTERS (UNII: 3AQ222F18X) SACCHARIDE ISOMERATE (UNII: W8K377W98I) POLYHYDROXYSTEARIC ACID (2300 MW) (UNII: YXH47AOU0F) LACTIC ACID, DL- (UNII: 3B8D35Y7S4) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) WATER (UNII: 059QF0KO0R) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) POLYMETHYLSILSESQUIOXANE (4.5 MICRONS) (UNII: 59Z907ZB69) GLYCERIN (UNII: PDC6A3C0OX) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42508-205-19 1 in 1 CARTON 04/19/2018 1 3000 mg in 1 TUBE; 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 04/19/2018 Labeler - Arbonne International, LLC (021541164) Registrant - Autumn Harp, Inc. (064187883) Establishment Name Address ID/FEI Business Operations Autumn Harp, Inc. 064187883 manufacture(42508-205)