NDC | 42508-016-06 |
Set ID | ee28bd3f-3433-4696-8cac-c59214da15e4 |
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
-
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
- children under 6 months of age: ask a doctor
- Other information
-
Inactive ingredients
water, C12-15 alkyl benzoate, glycerin, isononyl isononanoate, saccharide isomerate, steareth-21, squalane, ammonium acryloyldimethyltaurate/VP copolymer, caprylic/capric triglyceride, dimethicone, steareth-2, aloe barbadensis leaf juice, hydrolyzed ceratonia siliqua seed extract, laminaria digitata extract, chamomilla recutita (matricaria) flower extract, sophora japonica flower extract, tripleurospermum maritimum extract, malachite extract, hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer, dehydroxanthan gum, tetrahexyldecyl ascorbate, dipotassium glycyrrhizate, menthol, adenosine, sodium hyaluronate, polyglyceryl-3 laurate, sorbitan oleate, sorbitan isostearate, myristic acid, palmitic acid, stearic acid, triethoxycaprylylsilane, polysorbate 60, propanediol, trisodium ethylenediamine disuccinate, sodium citrate, citric acid, caprylhydroxamic acid, caprylyl glycol, phenoxyethanol, chlorphenesin, sodium benzoate, potassium sorbate, sorbic acid.
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 50 mL Tube Carton
-
INGREDIENTS AND APPEARANCE
RE9 ADVANCED FOR MEN ANTI-AGING MOISTURIZER BROAD SPECTRUM SPF 15 SUNSCREEN
zinc oxide lotionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42508-016 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE 49.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Alkyl (C12-15) Benzoate (UNII: A9EJ3J61HQ) Glycerin (UNII: PDC6A3C0OX) Isononyl Isononanoate (UNII: S4V5BS6GCX) Saccharide Isomerate (UNII: W8K377W98I) Steareth-21 (UNII: 53J3F32P58) Squalane (UNII: GW89575KF9) Ammonium Acryloyldimethyltaurate/VP Copolymer (UNII: W59H9296ZG) Medium-Chain Triglycerides (UNII: C9H2L21V7U) Dimethicone (UNII: 92RU3N3Y1O) Steareth-2 (UNII: V56DFE46J5) Aloe Vera Leaf (UNII: ZY81Z83H0X) Phenoxyethanol (UNII: HIE492ZZ3T) Caprylyl Glycol (UNII: 00YIU5438U) Tetrahexyldecyl Ascorbate (UNII: 9LBV3F07AZ) Sorbitan Monooleate (UNII: 06XEA2VD56) Propanediol (UNII: 5965N8W85T) Chlorphenesin (UNII: I670DAL4SZ) Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer (100000 MPA.S at 1.5%) (UNII: 86FQE96TZ4) Palmitic Acid (UNII: 2V16EO95H1) Dehydroxanthan Gum (UNII: 63ZP7I1BQO) Stearic Acid (UNII: 4ELV7Z65AP) Trisodium Ethylenediamine Disuccinate (UNII: YA22H34H9Q) Caprylhydroxamic Acid (UNII: UPY805K99W) Glycyrrhizinate Dipotassium (UNII: CA2Y0FE3FX) Menthol, Unspecified Form (UNII: L7T10EIP3A) Citric Acid Monohydrate (UNII: 2968PHW8QP) Sodium Citrate, Unspecified Form (UNII: 1Q73Q2JULR) Adenosine (UNII: K72T3FS567) Triethoxycaprylylsilane (UNII: LDC331P08E) Polysorbate 60 (UNII: CAL22UVI4M) Hyaluronate Sodium (UNII: YSE9PPT4TH) Sorbitan Isostearate (UNII: 01S2G2C1E4) Sodium Benzoate (UNII: OJ245FE5EU) Laminaria Digitata (UNII: 15E7C67EE8) Myristic Acid (UNII: 0I3V7S25AW) Chamomile (UNII: FGL3685T2X) Styphnolobium Japonicum Flower (UNII: 644C3CSB6E) Potassium Sorbate (UNII: 1VPU26JZZ4) Polyglyceryl-3 Laurate (UNII: Y9ZSR39D0E) Sorbic Acid (UNII: X045WJ989B) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42508-016-06 1 in 1 CARTON 04/14/2016 1 50 mL 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 04/14/2016 Labeler - Arbonne International, LLC (021541164)