![RE9 ADVANCED RESTORATIVE BROAD SPECTRUM SPF 15 SUNSCREEN (ZINC OXIDE) CREAM [ARBONNE INTERNATIONAL, LLC]](https://medic.hrt.org//dailymed/images/dd7511b9-3be0-4079-96f9-b885adb5c678/re9advanced-01.jpg)
| NDC | 42508-456-08 |
| Set ID | dd7511b9-3be0-4079-96f9-b885adb5c678 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Arbonne International, LLC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART352 |
- SPL UNCLASSIFIED SECTION
- Active ingredient
- Purpose
-
Uses
- helps prevent sunburn
- if used as directed with other sun protection measures (see Directions), decreases the risk of skin cancer and early skin aging caused by the sun
- 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, 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 a.m.–2 p.m.
- wear long-sleeved shirts, pants, hats, and sunglasses
- Other information
-
Inactive ingredients
water, C12-15 alkyl benzoate, glycerin, isononyl isononanoate, steareth-21, caprylic/capric triglyceride, squalane, dimethicone, sodium acryloyldimethyltaurate/VP crosspolymer, sorbitan oleate, steareth-2, aloe barbadensis leaf juice, citrus aurantium dulcis (orange) callus culture extract, cucumis sativus (cucumber) fruit extract, laminaria digitata extract, lavandula stoechas extract, pyrus malus (apple) fruit extract, nasturtium officinale extract, trifolium pratense (clover) flower extract, hippophae rhamnoides oil, olea europaea (olive) fruit oil, sodium hyaluronate, tetrahexyldecyl ascorbate, palmitoyl tripeptide-38, polyglyceryl-3 laurate, gluconolactone, xanthan gum, calcium gluconate, magnesium ascorbyl phosphate, tocopherol, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, dehydroxanthan gum, triethoxycaprylylsilane, polysorbate 60, sorbitan isostearate, sodium citrate, caprylhydroxamic acid, phytic acid, hydroxypropyl cyclodextrin, aminomethyl propanediol, citric acid, phenoxyethanol, chlorphenesin, potassium sorbate, sodium benzoate.
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 g Bottle Carton
-
INGREDIENTS AND APPEARANCE
RE9 ADVANCED RESTORATIVE BROAD SPECTRUM SPF 15 SUNSCREEN
zinc oxide creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42508-456 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 49 mg in 1 g Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ) GLYCERIN (UNII: PDC6A3C0OX) ISONONYL ISONONANOATE (UNII: S4V5BS6GCX) STEARETH-21 (UNII: 53J3F32P58) MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U) SQUALANE (UNII: GW89575KF9) DIMETHICONE (UNII: 92RU3N3Y1O) SORBITAN MONOOLEATE (UNII: 06XEA2VD56) STEARETH-2 (UNII: V56DFE46J5) ALOE VERA LEAF (UNII: ZY81Z83H0X) CUCUMBER (UNII: YY7C30VXJT) LAMINARIA DIGITATA (UNII: 15E7C67EE8) LAVANDULA STOECHAS FLOWERING TOP (UNII: 70759G2U6A) APPLE (UNII: B423VGH5S9) NASTURTIUM OFFICINALE (UNII: YH89GMV676) TRIFOLIUM PRATENSE FLOWER (UNII: 4JS0838828) OLIVE OIL (UNII: 6UYK2W1W1E) HYALURONATE SODIUM (UNII: YSE9PPT4TH) TETRAHEXYLDECYL ASCORBATE (UNII: 9LBV3F07AZ) PALMITOYL LYSYLDIOXYMETHIONYLLYSINE (UNII: T7A529FB8O) POLYGLYCERYL-3 LAURATE (UNII: Y9ZSR39D0E) GLUCONOLACTONE (UNII: WQ29KQ9POT) XANTHAN GUM (UNII: TTV12P4NEE) CALCIUM GLUCONATE (UNII: SQE6VB453K) MAGNESIUM ASCORBYL PHOSPHATE (UNII: 0R822556M5) TOCOPHEROL (UNII: R0ZB2556P8) DEHYDROXANTHAN GUM (UNII: 63ZP7I1BQO) TRIETHOXYCAPRYLYLSILANE (UNII: LDC331P08E) POLYSORBATE 60 (UNII: CAL22UVI4M) SORBITAN ISOSTEARATE (UNII: 01S2G2C1E4) ANHYDROUS TRISODIUM CITRATE (UNII: RS7A450LGA) CAPRYLHYDROXAMIC ACID (UNII: UPY805K99W) FYTIC ACID (UNII: 7IGF0S7R8I) AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) PHENOXYETHANOL (UNII: HIE492ZZ3T) CHLORPHENESIN (UNII: I670DAL4SZ) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) SODIUM BENZOATE (UNII: OJ245FE5EU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42508-456-08 1 in 1 CARTON 09/01/2018 1 50 g in 1 BOTTLE, PUMP; 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 09/01/2018 Labeler - Arbonne International, LLC (021541164)
